Allergic RhinitisPhase 1NCT05151133
Clinical Study of Allergic Rhinitis Therapy by Stem Cells
A Phase 1 study testing Low dose UCMSCs, Moderate dose UCMSCs and High dose UCMSCs in people with Allergic Rhinitis, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial summary
The investigators is now carrying out a clinical study of Umbilical cord Mesenchymal Stem Cells (UCMSCs) in the treatment of Allergic rhinitis (AR). UCMSCs is known to its multilineage differentiation potential, strong proliferation ability, low immunogenicity, convenient material acquisition, and fewer restrictions… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Low dose UCMSCs, Moderate dose UCMSCs and High dose UCMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2022to 15 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with moderate to severe persistent allergic rhinitis who meet the diagnostic criteria for allergic rhinitis (2015 Tianjin standard);
- The results of allergen examination showed that the allergen was a single allergy of dust mite;
- After more than 2 years of antihistamine, nasal glucocorticoid and other drug treatments, the curative effect is poor, and the symptoms seriously affect the patient's life;
- Age 18-60 years old;
- The patient refused to receive allergen-specific immunotherapy;
- The patient is willing to receive stem cell therapy and sign an informed consent.
Who cannot join
- The subject is accompanied by sinusitis, asthma and aspirin intolerance;
- The subjects suffer from severe primary heart, liver, lung, kidney and blood diseases;
- The subjects suffer from Malignant tumors;
- The subjects suffer from severe immune diseases;
- The subjects suffer from mental illness;
- Female subjects who are or are about to become pregnant, pregnant or breastfeeding;
- Patients who are participating in other clinical trials;
- In addition to the above conditions, there are other reasons why researchers believe that they are not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Yu Zhang, MD, 86 05356691999 ext. 83523, superzhang013@163.com
Peiwen Lian, PhD, 86 05356691999 ext. 82708, lianpeiwen@qq.com
About this study
Official title: Clinical Study of Moderate to Severe Persistent Allergic Rhinitis Therapy by Human Umbilical Cord Mesenchymal Stem Cells
The investigators is now carrying out a clinical study of Umbilical cord Mesenchymal Stem Cells (UCMSCs) in the treatment of Allergic rhinitis (AR). UCMSCs is known to its multilineage differentiation potential, strong proliferation ability, low immunogenicity, convenient material acquisition, and fewer restrictions on ethical and moral issues. The investigators hope to find a novel, minimally invasive, effective and simple treatment for the large number of patients with persistent moderate to severe AR.
Read the detailed description
Allergic rhinitis (AR), is a noninfectious inflammatory disease of nasal mucosa mediated by immunoglobulin E (IgE) antibody and involved in a variety of immune active cells and cytokines after the atopic body is exposed to allergens. The incidence of allergic rhinitis increases as people's living standards improves. It is estimated that about 1.4 billion people worldwide have been affected by the disease. Some patients with moderate to severe AR have no improvement in symptoms after drug treatment, which continues to affect daily life and work. Therefore, these patients urgently needs a new, minimally invasive, effective and simple treatment. Mesenchymal Stem Cells (MSCs) are pluripotent stem cells derived from the mesoderm, which can differentiate into bone, cartilage, fat and other cells. MSCs can also secrete a variety of bioactive molecules, which have the effects of regulating immunity and anti-inflammatory. Based on its immunomodulatory effect, MSCs is gradually becoming a new star in the treatment of allergic diseases. In pre-clinical studies on the treatment of AR, MSCs have shown good therapeutic effect in the treatment of allergic rhinitis.
This study is a prospective, open, single-center clinical study. Participants were recruited into three different dose groups. The cohort size of each dose group was 6 participants. The subjects of each group each will receive one course of treatment with a single injection. Subjects of group 1 will receive 0.5×10^6 cells/kg, with a total volume of 100 ml UCMSCs; group 2 will receive 1.0×10^6 cells/kg; with a total volume of 100 ml UCMSCs; group 3 will receive 2.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs. One month after each injection, the Data and Safety Monitoring Committee (DSMC) will comprehensively evaluate the results of the phased clinical research, and after determining the safety and feasibility of the research, the enrollment of the next phase will start. The subjects will be followed up on the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment. The main outcome measures are the severity and incidence of adverse events. The secondary outcome measures are RQLQ score, VAS score, serum inflammatory factor detection, nasal secretion inflammatory factor detection, nasal function test and nasal endoscopy, etc. In addition, the investigators will also monitor safety indicators such as blood routine, urine routine, liver and kidney function, immunological indicators, tumor markers, etc. At the end of the study, according to the data obtained, the clinical safety and feasibility of intravenous infusion of UCMSCs in the treatment of moderate to severe persistent AR will be evaluated, so as to provide drug dose basis for the next stage of clinical research.
- Conditions
- Allergic Rhinitis
- Being tested
- Low dose UCMSCs, Moderate dose UCMSCs, High dose UCMSCs
- Keywords
- Umbilical cord, Mesenchymal Stem Cells, Allergic Rhinitis, Therapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose UCMSCsBiological
Receive one course of treatment with a single injection : 0.5×10^6 cells/kg, with a total volume of 100 ml UCMSCs;
Moderate dose UCMSCsBiological
Receive one course of treatment with a single injection : 1.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs;
High dose UCMSCsBiological
Receive one course of treatment with a single injection : 2.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs;
| Study group | Role | What they receive |
|---|---|---|
| Low dose UCMSCs | Experimental | Not described Receives: Biological: Low dose UCMSCs |
| Moderate dose UCMSCs | Experimental | Not described Receives: Biological: Moderate dose UCMSCs |
| High dose UCMSCs | Experimental | Not described Receives: Biological: High dose UCMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and incidence of adverse events (SIAE) on the day of treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: Day 1 of treatment
3rd day SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 3 days after treatment
1 week SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 1 week after treatment
1 month SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 1 month after treatment
3 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 3 months after treatment
6 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 6 months after treatment
12 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 12 months after treatment
24 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Measured: 24 months after treatment
Secondary outcomes (29)
RQLQ score
The assessment of Rhinoconjunctivitis quality of life questionnaire (RQLQ) includes daily activities, sleep, non-rhino-conjunctivitis symptoms, rhinitis-related behaviors, nasal symptoms, eye symptoms, and emotional reactions.
Each of the above aspect is composed of several measurements. A total of 28 measurements are individually scored from 0 to 6 points. A score of 0 indicates that the subject has not been affected by nose and eye symptoms in the past week, a score of 1 indicates that it is almost unaffected, a score of 2 indicates a minor influence, a score of 3 indicates a slight influence, a score of 4 indicates a moderate influence, and a score of 5 indicates a severe influence, a score of 6 indicates that it is extremely severely affected. In terms of daily activities, a score of 9 directly indicates that daily activity cannot be carried out due to nose and eye symptoms.
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
VAS score
Visual analogue scale (VAS) is used to evaluate the severity of nasal symptoms by patients or their guardians. Visual line marks are made on the scale with a length of 10 cm. The VAS score is calculated as 0 is asymptomatic (0 cm), and 10 is the most serious symptom (10 cm).
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Nasal function test
Nasal expiratory nitric oxide (NO) test (NNO test), is a simple, noninvasive and convenient medical detection method, that can be used for the diagnosis, treatment and monitoring of nasal diseases such as rhinitis, sinusitis and nasal polyps.
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Nasal endoscopy
The normal nasal mucosa is light red, with smooth, moist and shiny surface. The nasal cavity and nasopharyngeal mucosa have no congestion, edema, dryness, ulcers, hemorrhage, vasodilatation and new organisms; no purulent secretions.
The mucosa of allergic rhinitis is pale, edematous or lavender, and the discharge is watery.
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
U-HCG
The U-HCG test detects levels of hCG in the urine, positive result indicate pregnacy.
Measured: The day of enrollment screening, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interferon γ (IFN-γ)
To test level of inflammatory factor Interferon γ (IFN-γ) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interferon α (IFN-α)
To test level of inflammatory factor Interferon α (IFN-α) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 1β (IL-1β)
To test level of inflammatory factor Interleukin 1β (IL-1β) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 2 (IL-2)
To test level of inflammatory factor Interleukin 2 (IL-2) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 4 (IL-4)
To test level of inflammatory factor Interleukin 4 (IL-4) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 5 (IL-5)
To test level of inflammatory factor Interleukin 5 (IL-5) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 6 (IL-6)
To test level of inflammatory factor Interleukin 6 (IL-6) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 8 (IL-8)
To test level of inflammatory factor Interleukin 8 (IL-8) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 10 (IL-10)
To test level of inflammatory factor Interleukin 10 (IL-10) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 12P70 (IL-12P70)
To test level of inflammatory factor Interleukin 12P70 (IL-12P70) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 17A (IL-17A)
To test level of inflammatory factor Interleukin 17A (IL-17A) in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Tumor necrosis factor-α（TNF-α）
To test level of inflammatory factor Tumor necrosis factor-α（TNF-α） in the serum;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interferon γ (IFN-γ) in nasal secretions
To test level of inflammatory factor Interferon γ (IFN-γ) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interferon α (IFN-α) in nasal secretions
To test level of inflammatory factor Interferon α (IFN-α) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 1β (IL-1β) in nasal secretions
To test level of inflammatory factor Interferon α (IFN-α) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 2 (IL-2) in nasal secretions
To test level of inflammatory factor Interleukin 2 (IL-2) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 4 (IL-4) in nasal secretions
To test level of inflammatory factor Interleukin 4 (IL-4) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 5 (IL-5) in nasal secretions
To test level of inflammatory factor Interleukin 5 (IL-5) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 6 (IL-6) in nasal secretions
To test level of inflammatory factor Interleukin 6 (IL-6) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 8 (IL-8) in nasal secretions
To test level of inflammatory factor Interleukin 8 (IL-8) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 10 (IL-10) in nasal secretions
To test level of inflammatory factor Interleukin 10 (IL-10) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions
To test level of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions
To test level of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Tumor necrosis factor-α（TNF-α） in nasal secretions
To test level of inflammatory factor Tumor necrosis factor-α（TNF-α） in nasal secretions;
Measured: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start13 Jun 2022
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xicheng Song, MD, Principal investigator, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151133
- Sponsor's protocol ID
- 2021-002
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Moderate to Severe Persistent Allergic Rhinitis Therapy by Human Umbilical Cord Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT05151133
- Acronym / sponsor ID
- 2021-002
- Conditions
- Allergic Rhinitis
- Keywords
- Umbilical cord, Mesenchymal Stem Cells, Allergic Rhinitis, Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators is now carrying out a clinical study of Umbilical cord Mesenchymal Stem Cells (UCMSCs) in the treatment of Allergic rhinitis (AR). UCMSCs is known to its multilineage differentiation potential, strong proliferation ability, low immunogenicity, convenient material acquisition, and fewer restrictions on ethical and moral issues. The investigators hope to find a novel, minimally invasive, effective and simple treatment for the large number of patients with persistent moderate to severe AR.
Detailed description
Allergic rhinitis (AR), is a noninfectious inflammatory disease of nasal mucosa mediated by immunoglobulin E (IgE) antibody and involved in a variety of immune active cells and cytokines after the atopic body is exposed to allergens. The incidence of allergic rhinitis increases as people's living standards improves. It is estimated that about 1.4 billion people worldwide have been affected by the disease. Some patients with moderate to severe AR have no improvement in symptoms after drug treatment, which continues to affect daily life and work. Therefore, these patients urgently needs a new, minimally invasive, effective and simple treatment. Mesenchymal Stem Cells (MSCs) are pluripotent stem cells derived from the mesoderm, which can differentiate into bone, cartilage, fat and other cells. MSCs can also secrete a variety of bioactive molecules, which have the effects of regulating immunity and anti-inflammatory. Based on its immunomodulatory effect, MSCs is gradually becoming a new star in the treatment of allergic diseases. In pre-clinical studies on the treatment of AR, MSCs have shown good therapeutic effect in the treatment of allergic rhinitis.
This study is a prospective, open, single-center clinical study. Participants were recruited into three different dose groups. The cohort size of each dose group was 6 participants. The subjects of each group each will receive one course of treatment with a single injection. Subjects of group 1 will receive 0.5×10^6 cells/kg, with a total volume of 100 ml UCMSCs; group 2 will receive 1.0×10^6 cells/kg; with a total volume of 100 ml UCMSCs; group 3 will receive 2.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs. One month after each injection, the Data and Safety Monitoring Committee (DSMC) will comprehensively evaluate the results of the phased clinical research, and after determining the safety and feasibility of the research, the enrollment of the next phase will start. The subjects will be followed up on the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment. The main outcome measures are the severity and incidence of adverse events. The secondary outcome measures are RQLQ score, VAS score, serum inflammatory factor detection, nasal secretion inflammatory factor detection, nasal function test and nasal endoscopy, etc. In addition, the investigators will also monitor safety indicators such as blood routine, urine routine, liver and kidney function, immunological indicators, tumor markers, etc. At the end of the study, according to the data obtained, the clinical safety and feasibility of intravenous infusion of UCMSCs in the treatment of moderate to severe persistent AR will be evaluated, so as to provide drug dose basis for the next stage of clinical research.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose UCMSCs | Experimental | Biological: Low dose UCMSCs |
| Moderate dose UCMSCs | Experimental | Biological: Moderate dose UCMSCs |
| High dose UCMSCs | Experimental | Biological: High dose UCMSCs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with moderate to severe persistent allergic rhinitis who meet the diagnostic criteria for allergic rhinitis (2015 Tianjin standard);
- The results of allergen examination showed that the allergen was a single allergy of dust mite;
- After more than 2 years of antihistamine, nasal glucocorticoid and other drug treatments, the curative effect is poor, and the symptoms seriously affect the patient's life;
- Age 18-60 years old;
- The patient refused to receive allergen-specific immunotherapy;
Key exclusion criteria (8 listed)
- The subject is accompanied by sinusitis, asthma and aspirin intolerance;
- The subjects suffer from severe primary heart, liver, lung, kidney and blood diseases;
- The subjects suffer from Malignant tumors;
- The subjects suffer from severe immune diseases;
- The subjects suffer from mental illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose UCMSCsReceive one course of treatment with a single injection : 0.5×10^6 cells/kg, with a total volume of 100 ml UCMSCs; | Biological | Low dose UCMSCs |
| Moderate dose UCMSCsReceive one course of treatment with a single injection : 1.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs; | Biological | Moderate dose UCMSCs |
| High dose UCMSCsReceive one course of treatment with a single injection : 2.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs; | Biological | High dose UCMSCs |
Primary outcome
Severity and incidence of adverse events (SIAE) on the day of treatment
Time frame: Day 1 of treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
3rd day SIAE
Time frame: 3 days after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
1 week SIAE
Time frame: 1 week after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
1 month SIAE
Time frame: 1 month after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
3 months SIAE
Time frame: 3 months after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
6 months SIAE
Time frame: 6 months after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
12 months SIAE
Time frame: 12 months after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
24 months SIAE
Time frame: 24 months after treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
29 secondary outcomes
RQLQ score
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
VAS score
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Nasal function test
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Nasal endoscopy
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
U-HCG
Time frame: The day of enrollment screening, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interferon γ (IFN-γ)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interferon α (IFN-α)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 1β (IL-1β)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 2 (IL-2)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 4 (IL-4)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 5 (IL-5)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 6 (IL-6)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 8 (IL-8)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 10 (IL-10)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 12P70 (IL-12P70)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Interleukin 17A (IL-17A)
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of Serum Tumor necrosis factor-α（TNF-α）
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interferon γ (IFN-γ) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interferon α (IFN-α) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 1β (IL-1β) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 2 (IL-2) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 4 (IL-4) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 5 (IL-5) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 6 (IL-6) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 8 (IL-8) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 10 (IL-10) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Detection of inflammatory factor Tumor necrosis factor-α（TNF-α） in nasal secretions
Time frame: The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xicheng Song, MD principal investigator
Yantai Yuhuangding Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose UCMSCs, Moderate dose UCMSCs and High dose UCMSCs in people with Allergic Rhinitis, run by Yantai Yuhuangding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, MD (86 05356691999 ext. 83523, superzhang013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and incidence of adverse events (SIAE) on the day of treatment (time frame: Day 1 of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.