Long COVIDPhase 1/2NCT06492798
Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
A Phase 1/2 study testing umbilical cord mesenchymal stem cell in people with Long COVID and Post-Acute COVID-19 Syndrome, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include: whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients whether umbilical cord mesenchymal stem cell therapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Long COVID, Post-Acute COVID-19 Syndrome
- What is being tested?
- umbilical cord mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Aug 2026
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria for Long COVID according to WHO.
- Main symptoms assessed based on CTCAE 5.0.
- Symptoms evaluated for exclusion reasons of other diseases by relevant specialists.
- No recent plans for pregnancy (negative pregnancy test within 72 hours for women of childbearing age prior to the start of the trial), and willing to use effective non-pharmaceutical contraceptive measures during the study.
- Signed informed consent forms and agreements to participate in this clinical trial.
Who cannot join
- Active malignant tumors.
- Active infections.
- Abnormal liver or kidney function (ALT, AST > 2 times the upper limit of normal; Cr > 2 times the upper limit of normal).
- Women who are pregnant, lactating, or planning to become pregnant during the trial.
- Participated in other clinical trials within the last 3 months prior to screening.
- Other reasons deemed inappropriate for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai, 200433
Yuchao Dong, Doctor, +86 021-31161314, dongyc1020@aliyun.com
About this study
The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include:
- whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients
- whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients.
Read more
Participants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted.
Participants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that.
Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.
Read the detailed description
Since the outbreak of the COVID-19 pandemic, according to the official statistics from the WHO website, there have been over 694 million confirmed cases worldwide until August 2023, with approximately 6.9 million deaths. In addition to the high incidence and mortality rates in the initial weeks following infection, up to 70% of COVID-19 patients may experience long-term complications, significantly impacting human health and placing a substantial burden on hospital resources.
A study evaluated 2,320 adult participants who were discharged between March 7, 2020, and April 18, 2021 from several National Health Service (NHS) hospitals in the United Kingdom, and found that only 25.5% of COVID-19 patients had fully recovered five months after discharge. And the improvement in patients' conditions was minimal even when study period was extended to one year. 71% of patients continued to experience one or more post-COVID-19 sequelae, with common symptoms including fatigue, difficulty breathing, muscle pain, and insomnia, etc. According to multiple studies, post-COVID-19 sequelae may involve 203 different symptoms and affect 10 organ systems in the body, including the neurological, reproductive, cardiovascular, and pulmonary systems. The World Health Organization (WHO) published an official definition of long COVID in October 2021. They define it as a condition that "occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis." Despite some guidelines for the management of long COVID, there is still a lack of specific treatment methods. Currently, the most important strategy is vaccination. Vaccination can help alleviate symptoms during the acute infection period, and studies have found that individuals who are vaccinated against COVID-19 have approximately a 50% lower risk of developing long COVID compared to those who are unvaccinated. Also, there are other therapies that are in the clinical research stage, and one of which is stem cell therapy. Mesenchymal stem cells (MSCs) are a type of cell with self-renewal and multi-directional differentiation abilities. They are the primitive "seed cells" that form various tissues and organs in the human body. Under specific conditions, MSCs can differentiate into various cells in the human body, including osteoblasts, adipocytes, chondrocytes, and other cells of the stromal lineage, and repair tissue damage through the secretion of corresponding factors. Meanwhile, MSCs also act as "inflammation terminators" by regulating immune reactions through paracrine functions and interactions with immune cells. This ultimately leads to the downregulation of local inflammatory responses and alleviation of excessive immune reactions.
The research team led by Wang Fusheng published a study in the journal "eBioMedicine" (impact factor: 8.143) in 2022, which explored the use of umbilical cord mesenchymal stem cells (UC-MSCs) for the treatment of severe COVID-19 patients and followed up patients for one year. The study confirmed that UC-MSCs therapy, as an adjuvant therapy, has long-term benefits for lung injury in severe COVID-19 patients. This was a randomized, double-blind, controlled trial, with 100 patients randomly assigned in a 2:1 ratio (65 in the UC-MSCs group and 35 in the control group). The results showed that UC-MSCs helped in the resolution of lung consolidative lesions, with 17.9% of patients in the UC-MSCs group having normal CT images after one year of follow-up. In contrast, the control placebo group had not recovered from lung injury. There were no significant differences in the incidence of adverse events between the two groups. And in Japan, the Japanese Respiratory Syndrome Society has been conducting research on the long-term effects of COVID-19 since August 1, 2020. According to foreign media reports, the Kyushu Regenerative Medicine Special Committee in Japan has approved a program for the use of autologous adipose-derived mesenchymal stem cells in the treatment of post-COVID-19 syndrome. This patented technology developed by the Korean Stem Cell Research Institute has undergone a 120-day review and three rounds of screening by a committee of 16 experts from various fields, and has passed the review of the current regenerative medical plan for post-COVID-19 syndrome. The director of the Stem Cell Research Institute, who developed this therapy, stated, "This approval has received strong support from the Regenerative Medicine Special Committee. The investigators believe that mesenchymal stem cells, through their anti-inflammatory and tissue regeneration effects, will have good results in treating post-COVID-19 syndrome." This study aims to evaluate the effectiveness and safety of mesenchymal cell therapy for long COVID-19 patients. It is a prospective exploratory study, randomized, double-blind, placebo-controlled trial, planning to include a total of 76 patients who have been infected with COVID-19. By assessing the improvement of CTCAE 5.0 symptom scores in the treatment group and control group at 28 days, 12 weeks, and 24 weeks after treatment completion, the effectiveness and safety of mesenchymal stem cells in patients with long- term COVID-19 will be evaluated. This study is divided into two stages. Stage one: 10 patients will be enrolled, all receiving mesenchymal stem cell treatment, primarily assessing their safety. Stage two: 66 patients will be enrolled, randomly assigned in a 1:1 ratio to the treatment group and control group, evaluating the effectiveness and safety of mesenchymal stem cell therapy for long-term COVID-19.
- Conditions
- Long COVID, Post-Acute COVID-19 Syndrome
- Being tested
- umbilical cord mesenchymal stem cell
- Keywords
- Post-Acute COVID-19 Syndrome, Mesenchymal stem cell, Effectiveness, Safety
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellDrug
Also called MSCs
intravenous infusion of umbilical cord mesenchymal stem cell
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants will receive intravenous infusion of MSCs once or an additional infusion on days 35-42.
Dosage: 1×10^6 cells per kilogram of body weight Specification: 1×10^7 cells/100ml Receives: Drug: umbilical cord mesenchymal stem cell |
| Placebo group | Placebo comparator | Participants will receive intravenous infusion of placebo Dosage: 10ml per kilogram of body weight Receives: Drug: umbilical cord mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common Terminology Criteria for Adverse Events (CTCAE5.0)
CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.
Measured: 28th day
Secondary outcomes (1)
Common Terminology Criteria for Adverse Events (CTCAE5.0)
CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.
Measured: 12th week, 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Yuchao, Changhai Hospital
- Investigators
- Yuchao Dong, Doctor, Study director, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492798
- Sponsor's protocol ID
- MSCinLong-COVID
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study information, including study protocol, statistical analysis plan, informed consent form, clinical study report will be available immediately upon the data being de-identified and properly revised for quality control on the study website.
Publications
Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
PubMed 34951953Ledford H. Can drugs reduce the risk of long COVID? What scientists know so far. Nature. 2022 Apr;604(7904):20-21. doi: 10.1038/d41586-022-00823-y. No abstract available.
PubMed 35338366Chen L, Qu J, Kalyani FS, Zhang Q, Fan L, Fang Y, Li Y, Xiang C. Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications. Cell Mol Life Sci. 2022 Feb 20;79(3):142. doi: 10.1007/s00018-021-04096-y.
PubMed 35187617Yousefi Dehbidi M, Goodarzi N, Azhdari MH, Doroudian M. Mesenchymal stem cells and their derived exosomes to combat Covid-19. Rev Med Virol. 2022 Mar;32(2):e2281. doi: 10.1002/rmv.2281. Epub 2021 Aug 7.
PubMed 34363275Rebelatto CLK, Senegaglia AC, Franck CL, Daga DR, Shigunov P, Stimamiglio MA, Marsaro DB, Schaidt B, Micosky A, de Azambuja AP, Leitao CA, Petterle RR, Jamur VR, Vaz IM, Mallmann AP, Carraro Junior H, Ditzel E, Brofman PRS, Correa A. Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial. Stem Cell Res Ther. 2022 Mar 21;13(1):122. doi: 10.1186/s13287-022-02796-1.
PubMed 35313959Zhao F, Ma Q, Yue Q, Chen H. SARS-CoV-2 Infection and Lung Regeneration. Clin Microbiol Rev. 2022 Apr 20;35(2):e0018821. doi: 10.1128/cmr.00188-21. Epub 2022 Feb 2.
PubMed 35107300Shi L, Wang L, Xu R, Zhang C, Xie Y, Liu K, Li T, Hu W, Zhen C, Wang FS. Mesenchymal stem cell therapy for severe COVID-19. Signal Transduct Target Ther. 2021 Sep 8;6(1):339. doi: 10.1038/s41392-021-00754-6.
PubMed 34497264Meng F, Xu R, Wang S, Xu Z, Zhang C, Li Y, Yang T, Shi L, Fu J, Jiang T, Huang L, Zhao P, Yuan X, Fan X, Zhang JY, Song J, Zhang D, Jiao Y, Liu L, Zhou C, Maeurer M, Zumla A, Shi M, Wang FS. Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial. Signal Transduct Target Ther. 2020 Aug 27;5(1):172. doi: 10.1038/s41392-020-00286-5.
PubMed 32855385Shi L, Yuan X, Yao W, Wang S, Zhang C, Zhang B, Song J, Huang L, Xu Z, Fu JL, Li Y, Xu R, Li TT, Dong J, Cai J, Li G, Xie Y, Shi M, Li Y, Zhang Y, Xie WF, Wang FS. Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2022 Jan;75:103789. doi: 10.1016/j.ebiom.2021.103789. Epub 2021 Dec 25.
PubMed 34963099Shi L, Huang H, Lu X, Yan X, Jiang X, Xu R, Wang S, Zhang C, Yuan X, Xu Z, Huang L, Fu JL, Li Y, Zhang Y, Yao WQ, Liu T, Song J, Sun L, Yang F, Zhang X, Zhang B, Shi M, Meng F, Song Y, Yu Y, Wen J, Li Q, Mao Q, Maeurer M, Zumla A, Yao C, Xie WF, Wang FS. Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2021 Feb 10;6(1):58. doi: 10.1038/s41392-021-00488-5.
PubMed 33568628Zhou T, Yuan Z, Weng J, Pei D, Du X, He C, Lai P. Challenges and advances in clinical applications of mesenchymal stromal cells. J Hematol Oncol. 2021 Feb 12;14(1):24. doi: 10.1186/s13045-021-01037-x.
PubMed 33579329
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
- ClinicalTrials.gov ID
- NCT06492798
- Acronym / sponsor ID
- MSCinLong-COVID
- Conditions
- Long COVID, Post-Acute COVID-19 Syndrome
- Keywords
- Post-Acute COVID-19 Syndrome, Mesenchymal stem cell, Effectiveness, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Jul 2024 (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 goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include:
- whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients
- whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients.
Participants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted.
Participants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that.
Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.
Detailed description
Since the outbreak of the COVID-19 pandemic, according to the official statistics from the WHO website, there have been over 694 million confirmed cases worldwide until August 2023, with approximately 6.9 million deaths. In addition to the high incidence and mortality rates in the initial weeks following infection, up to 70% of COVID-19 patients may experience long-term complications, significantly impacting human health and placing a substantial burden on hospital resources.
A study evaluated 2,320 adult participants who were discharged between March 7, 2020, and April 18, 2021 from several National Health Service (NHS) hospitals in the United Kingdom, and found that only 25.5% of COVID-19 patients had fully recovered five months after discharge. And the improvement in patients' conditions was minimal even when study period was extended to one year. 71% of patients continued to experience one or more post-COVID-19 sequelae, with common symptoms including fatigue, difficulty breathing, muscle pain, and insomnia, etc. According to multiple studies, post-COVID-19 sequelae may involve 203 different symptoms and affect 10 organ systems in the body, including the neurological, reproductive, cardiovascular, and pulmonary systems. The World Health Organization (WHO) published an official definition of long COVID in October 2021. They define it as a condition that "occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis." Despite some guidelines for the management of long COVID, there is still a lack of specific treatment methods. Currently, the most important strategy is vaccination. Vaccination can help alleviate symptoms during the acute infection period, and studies have found that individuals who are vaccinated against COVID-19 have approximately a 50% lower risk of developing long COVID compared to those who are unvaccinated. Also, there are other therapies that are in the clinical research stage, and one of which is stem cell therapy. Mesenchymal stem cells (MSCs) are a type of cell with self-renewal and multi-directional differentiation abilities. They are the primitive "seed cells" that form various tissues and organs in the human body. Under specific conditions, MSCs can differentiate into various cells in the human body, including osteoblasts, adipocytes, chondrocytes, and other cells of the stromal lineage, and repair tissue damage through the secretion of corresponding factors. Meanwhile, MSCs also act as "inflammation terminators" by regulating immune reactions through paracrine functions and interactions with immune cells. This ultimately leads to the downregulation of local inflammatory responses and alleviation of excessive immune reactions.
The research team led by Wang Fusheng published a study in the journal "eBioMedicine" (impact factor: 8.143) in 2022, which explored the use of umbilical cord mesenchymal stem cells (UC-MSCs) for the treatment of severe COVID-19 patients and followed up patients for one year. The study confirmed that UC-MSCs therapy, as an adjuvant therapy, has long-term benefits for lung injury in severe COVID-19 patients. This was a randomized, double-blind, controlled trial, with 100 patients randomly assigned in a 2:1 ratio (65 in the UC-MSCs group and 35 in the control group). The results showed that UC-MSCs helped in the resolution of lung consolidative lesions, with 17.9% of patients in the UC-MSCs group having normal CT images after one year of follow-up. In contrast, the control placebo group had not recovered from lung injury. There were no significant differences in the incidence of adverse events between the two groups. And in Japan, the Japanese Respiratory Syndrome Society has been conducting research on the long-term effects of COVID-19 since August 1, 2020. According to foreign media reports, the Kyushu Regenerative Medicine Special Committee in Japan has approved a program for the use of autologous adipose-derived mesenchymal stem cells in the treatment of post-COVID-19 syndrome. This patented technology developed by the Korean Stem Cell Research Institute has undergone a 120-day review and three rounds of screening by a committee of 16 experts from various fields, and has passed the review of the current regenerative medical plan for post-COVID-19 syndrome. The director of the Stem Cell Research Institute, who developed this therapy, stated, "This approval has received strong support from the Regenerative Medicine Special Committee. The investigators believe that mesenchymal stem cells, through their anti-inflammatory and tissue regeneration effects, will have good results in treating post-COVID-19 syndrome." This study aims to evaluate the effectiveness and safety of mesenchymal cell therapy for long COVID-19 patients. It is a prospective exploratory study, randomized, double-blind, placebo-controlled trial, planning to include a total of 76 patients who have been infected with COVID-19. By assessing the improvement of CTCAE 5.0 symptom scores in the treatment group and control group at 28 days, 12 weeks, and 24 weeks after treatment completion, the effectiveness and safety of mesenchymal stem cells in patients with long- term COVID-19 will be evaluated. This study is divided into two stages. Stage one: 10 patients will be enrolled, all receiving mesenchymal stem cell treatment, primarily assessing their safety. Stage two: 66 patients will be enrolled, randomly assigned in a 1:1 ratio to the treatment group and control group, evaluating the effectiveness and safety of mesenchymal stem cell therapy for long-term COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: umbilical cord mesenchymal stem cellParticipants will receive intravenous infusion of MSCs once or an additional infusion on days 35-42. Dosage: 1×10^6 cells per kilogram of body weight Specification: 1×10^7 cells/100ml |
| Placebo group | Placebo comparator | Drug: umbilical cord mesenchymal stem cellParticipants will receive intravenous infusion of placebo Dosage: 10ml per kilogram of body weight |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meeting the diagnostic criteria for Long COVID according to WHO.
- Main symptoms assessed based on CTCAE 5.0.
- Symptoms evaluated for exclusion reasons of other diseases by relevant specialists.
- No recent plans for pregnancy (negative pregnancy test within 72 hours for women of childbearing age prior to the start of the trial), and willing to use effective non-pharmaceutical contraceptive measures during the study.
- Signed informed consent forms and agreements to participate in this clinical trial.
Key exclusion criteria (6 listed)
- Active malignant tumors.
- Active infections.
- Abnormal liver or kidney function (ALT, AST > 2 times the upper limit of normal; Cr > 2 times the upper limit of normal).
- Women who are pregnant, lactating, or planning to become pregnant during the trial.
- Participated in other clinical trials within the last 3 months prior to screening.
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 |
|---|---|---|
| umbilical cord mesenchymal stem cellAlso: MSCsintravenous infusion of umbilical cord mesenchymal stem cell | Drug | Placebo group, Treatment group |
Primary outcome
Common Terminology Criteria for Adverse Events (CTCAE5.0)
Time frame: 28th day
CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.
1 secondary outcome
Common Terminology Criteria for Adverse Events (CTCAE5.0)
Time frame: 12th week, 24th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 34951953Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
- Background: PubMed 35338366Ledford H. Can drugs reduce the risk of long COVID? What scientists know so far. Nature. 2022 Apr;604(7904):20-21. doi: 10.1038/d41586-022-00823-y. No abstract available.
- Background: PubMed 35187617Chen L, Qu J, Kalyani FS, Zhang Q, Fan L, Fang Y, Li Y, Xiang C. Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications. Cell Mol Life Sci. 2022 Feb 20;79(3):142. doi: 10.1007/s00018-021-04096-y.
- Background: PubMed 34363275Yousefi Dehbidi M, Goodarzi N, Azhdari MH, Doroudian M. Mesenchymal stem cells and their derived exosomes to combat Covid-19. Rev Med Virol. 2022 Mar;32(2):e2281. doi: 10.1002/rmv.2281. Epub 2021 Aug 7.
- Background: PubMed 35313959Rebelatto CLK, Senegaglia AC, Franck CL, Daga DR, Shigunov P, Stimamiglio MA, Marsaro DB, Schaidt B, Micosky A, de Azambuja AP, Leitao CA, Petterle RR, Jamur VR, Vaz IM, Mallmann AP, Carraro Junior H, Ditzel E, Brofman PRS, Correa A. Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial. Stem Cell Res Ther. 2022 Mar 21;13(1):122. doi: 10.1186/s13287-022-02796-1.
- Background: PubMed 35107300Zhao F, Ma Q, Yue Q, Chen H. SARS-CoV-2 Infection and Lung Regeneration. Clin Microbiol Rev. 2022 Apr 20;35(2):e0018821. doi: 10.1128/cmr.00188-21. Epub 2022 Feb 2.
- Background: PubMed 34497264Shi L, Wang L, Xu R, Zhang C, Xie Y, Liu K, Li T, Hu W, Zhen C, Wang FS. Mesenchymal stem cell therapy for severe COVID-19. Signal Transduct Target Ther. 2021 Sep 8;6(1):339. doi: 10.1038/s41392-021-00754-6.
- Background: PubMed 32855385Meng F, Xu R, Wang S, Xu Z, Zhang C, Li Y, Yang T, Shi L, Fu J, Jiang T, Huang L, Zhao P, Yuan X, Fan X, Zhang JY, Song J, Zhang D, Jiao Y, Liu L, Zhou C, Maeurer M, Zumla A, Shi M, Wang FS. Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial. Signal Transduct Target Ther. 2020 Aug 27;5(1):172. doi: 10.1038/s41392-020-00286-5.
- Background: PubMed 34963099Shi L, Yuan X, Yao W, Wang S, Zhang C, Zhang B, Song J, Huang L, Xu Z, Fu JL, Li Y, Xu R, Li TT, Dong J, Cai J, Li G, Xie Y, Shi M, Li Y, Zhang Y, Xie WF, Wang FS. Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2022 Jan;75:103789. doi: 10.1016/j.ebiom.2021.103789. Epub 2021 Dec 25.
- Background: PubMed 33568628Shi L, Huang H, Lu X, Yan X, Jiang X, Xu R, Wang S, Zhang C, Yuan X, Xu Z, Huang L, Fu JL, Li Y, Zhang Y, Yao WQ, Liu T, Song J, Sun L, Yang F, Zhang X, Zhang B, Shi M, Meng F, Song Y, Yu Y, Wen J, Li Q, Mao Q, Maeurer M, Zumla A, Yao C, Xie WF, Wang FS. Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2021 Feb 10;6(1):58. doi: 10.1038/s41392-021-00488-5.
- Background: PubMed 33579329Zhou T, Yuan Z, Weng J, Pei D, Du X, He C, Lai P. Challenges and advances in clinical applications of mesenchymal stromal cells. J Hematol Oncol. 2021 Feb 12;14(1):24. doi: 10.1186/s13045-021-01037-x.
- Individual participant dataSharing planned: Yes. Study information, including study protocol, statistical analysis plan, informed consent form, clinical study report will be available immediately upon the data being de-identified and properly revised for quality control on the study website.
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Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
Yuchao Dong, Doctor study director
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cell in people with Long COVID and Post-Acute COVID-19 Syndrome, run by Changhai 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 5 inclusion and 6 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 9 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yuchao Dong, Doctor (+86 021-31161314, dongyc1020@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Terminology Criteria for Adverse Events (CTCAE5.0) (time frame: 28th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492798, which also lists 11 linked publications.
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 9 Jul 2024.