Hematologic NeoplasmsPhase 1/2NCT05672420
Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies
A Phase 1/2 study testing umbilical cord derived mesenchymal stem cells in people with Hematologic Neoplasms and Neutropenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
Trial summary
The purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematologic Neoplasms, Neutropenia, Anemia
- What is being tested?
- umbilical cord derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2023to 31 Jan 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years old;
- Either type of primary hematologic malignancies listed below:
- Acute myeloid leukemia (AML, AML subtype M3 excluded) or acute lymphoblastic leukemia (ALL) diagosed according to the 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia, either treatment naive participants who are going to receive first induction therapy, or participants who failed first induction therapy and are going to receive re-inducton therapy;
- AML or ALL participants who achieved remission and are going to receive consolidation therapy;
- Relapsed/refractory AML or ALL participants who are going to receive first re-induction therapy;
- Phase II trial will also include: participants with primary hematological maligancies who are going to receive autologous hematopoietic stem cell transplantation (allo-HSCT) whereas are poor mobilizers (CD34+cell count in peripheral blood was below 11-19/μL before collection, or the amount of CD34+ cells transfused was below 2×10^6/kg in allo-HSCT), and the participants' peripheral superficial veins have smooth blood flow which can meet the demand for intravenous drip;
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- The participant or his/her legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with signed informed consent;
- Male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day anti-cancer therapy is initiated)
- Estimated survival of at least 3 months;
- Adequate major organ function:
- Respiratory function: indoor oxygen saturation of at least 95%;
- Cardiac function: ejection fraction of left ventricular of at least 45%;
- Hepatic function: alanine aminotransferase/aspartate aminotransferase of at most 2.5 times/upper limit of normal value and serum total bilirubin of at most 1.5 times/upper limit of normal value;
- Renal function: Serum creatinine of at most 1.5 times/upper limit of normal value;
- Participants who do not receive any type of anti-cancer therapy within 2 weeks before enrollment (radiation therapy, chemotherapy and/or immune therapy, et al.), and treatment-associated toxicities induced by previous therapy has recovered to Grade 1 or below (except for low grade toxities such as alopecia).
Who cannot join
- Overt central nervous system manifestations of hematologic malignancies at diagnosis;
- Secondary hematological maligancies;
- Body mass index (BMI) of more than 30 kg/m^2;
- Myelosuppression induced by conditions other than anti-cancer therapy;
- Previous radiation therapy performed on sternum or pelvis;
- Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is defined as exhibiting ongoing signs and symptoms of infection without improvement despite anti-infective agents) ;
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- Uncontrolled active bleeding at enrollment;
- Severe underlying comorbidities affecting survival, including cachexia, severe malnutrition, etc;
- Estimated survival of at most 48 hours;
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- History of or current human immunodeficiency virus (HIV) infection;
- Continuous usage of immunosuppressants or received organ transplantation in the last 6 months;
- Participation in clinical trials of other drugs within 6 weeks before enrollment;
- Previous participation in clinical stem cell research;
- Receiving any agent concurrently with UC-MSCs infusion which inhibits cell division (hydroxyurea, low-dose cytarabine or methotrexate, etc) ;
- Severe allergic constitution, or known or suspected allergy to the study drug and its components;
- Known contraindication to receiving hematopoietic growth factors, transfusion of blood components, anti-infective agents;
- Female participants who are pregnant or breast feeding;
- Participants with fertility plan;
- Note: For female participants, they should be surgical sterilized or post-menopausal, or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study; For male participants, they should be surgical sterilized or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study;
- Participants suffering from mental illness;
- Presence of drug abuse/addiction;
- History of other malignancies other than hematological malignancies within 3 years;
- Participants without signed informed consent;
- Participants with poor compliance and are unable to complete the whole course of the study;
- Participants with circumstances that, in the opinion of the investigator, may increase the risk of the participants or interfere with conduct of the clinical trial and the judgment of results (excessive tension, sensitivity or cognitive impairment, etc) ;
- Participants with other circumstances that are ineligible for enrollment in this study, in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Wuhan Central Hospital
Wuhan, Hubei, 430014
Hongxiang Wang, Professor, whitely1972@sina.com
Hongxiang Wang, Professor
Wuhan Union Hospital
Wuhan, Hubei, 430022
Qiubai Li, Professor, (027) 85726387, qiubaili@hust.edu.cn
Qiubai Li, Professor
Wuhan Tongji Hospital
Wuhan, Hubei, 430030
Yicheng Zhang, Professor, yczhang@tjh.tjmu.edu.cn
Yicheng Zhang, Professor
About this study
Official title: A Multicenter, Phase Ib/II Trial of the Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells in Treatment-induced Myelosuppression in Patients With Hematologic Malignancies (USMYE Trial)
The purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies.
Read the detailed description
Despite the improved prognosis of patients with hematologic malignancies, almost all patients will experience severe myelosuppression induced by anti-cancer treatment, leading to a series of complications such as infection due to neutropenia, bleeding due to thrombocytopenia and/or impaired major organ function such as cardiac function due to anemia, which are the main reasons for dose reduction, dose interrruptions of anti-cancer treatment, failure of hematopoietic stem cell transplantation, and also patients' treatment-related death. It is of significant clinical importance and an urgent need to promote early recovery of myelosuppression and reduce risks of related complications as well as medical burdens. Umbilical cord derived mesenchymal stem cells (UC-MSCs), as a kind of stem cells with multipotential, can widely act on the functional cell units of bone marrow microenvironment and promote the repairment and regeneration of key cells such as hematopoietic stem cells, mesenchymal stem cells and endothelial cells, thus making it an ideal means for effectively promoting recovery of myelosuppression. Patients with hematologic malignancies and treatment-induced myelosuppression will be invited to participate in the Phase Ib/II study, to receive UC-MSCs intravenous infusion and follow-up visits of up to 2 years after enrollment.
- Conditions
- Hematologic Neoplasms, Neutropenia, Anemia, Thrombocytopenia, Infections, Bleeding
- Being tested
- umbilical cord derived mesenchymal stem cells
- Keywords
- umbilical cord derived mesenchymal stem cells, treatment-induced myelosuppression, neutropenia, anemia, thrombocytopenia, infections, bleeding, hematologic malignancies, leukemia, lymphoma, multiple myeloma, chemotherapy, targeted therapy, hematopoietic stem cell transplantation
- Medical subject headings
- Hematologic Neoplasms, Neutropenia, Anemia, Thrombocytopenia, Infections, Hemorrhage, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord derived mesenchymal stem cellsBiological
umbilical cord derived mesenchymal stem cells, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord derived mesenchymal stem cells (UC-MSCs) | Experimental | In the Phase Ib study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia, UC-MSCs will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, frequency of infusion will be preset with 3 escalation levels: frequency 1, frequency 2, frequency 3, total course of treatment: 2 weeks; In the Phase II study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia/primary hematological maligancies who are going to receive hematopoietic stem cell transplantation, UC-MSCs will be preset according to the recommended phase II dose (RP2D) from the Phase Ib study, total course of treatment: 2 weeks. Receives: Biological: umbilical cord derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities（DLT)
During the DLT observation period, the subject has an adverse event that is reasonably related to UC-MSCs infusion (possibly, likely or definitely related).
Measured: 4 days after the last UC-MSCs dose, up to 12 days
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.
Measured: From the day that the last UC-MSCs dose is used to up to 21 days
Maximum tolerated dose (MTD)
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/3 in the dose group of at least 6 evaluble subjects of the study drug after the last UC-MSCs dose.
Measured: From the day that the last UC-MSCs dose is used to up to 4 days
Secondary outcomes (20)
Time to absolute neutrophil count recovery
To investigate the efficacy characteristics, time will be measured in days.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of febrile neutropenia
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of febrile neutropenia
To investigate the efficacy characteristics, the duration will be measured in days.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of severe thrombocytopenia
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to severe thrombocytopenia recovery
To investigate the efficacy characteristics, time will be measured in days.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of severe anemia
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to severe anemia recovery
To investigate the efficacy characteristics, time will be measured in days.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of infetion
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of infetion
To investigate the efficacy characteristics, the duration will be measured in days.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of bleeding
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of bleeding
To investigate the efficacy characteristics, the duration will be measured in days.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Application rate of blood transfusion
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Application rate of anti-infective agents
To investigate the efficacy characteristics, percentages will be calculated.
Measured: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to achievement of complete remission
To investigate the efficacy characteristics, time will be measured in days.
Measured: From enrollment to up to 28 days
Duration of complete remission
To investigate the safety characteristics, the duration will be measured in days or months.
Measured: From enrollment to maximun up to 2 years
Event free survival
From enrollment to the day of any event.
Measured: From enrollment to maximun up to 2 years
Overall survival
From enrollment to the day of death caused by any reason.
Measured: From enrollment to maximun up to 2 years
Incidence of infusion reactions in 2 years
To investigate the safety characteristics, percentages will be calculated.
Measured: 2 years since the last UC-MSCs infusion
Incidence of secondary tumor in 2 years
To investigate the safety characteristics, percentages will be calculated.
Measured: 2 years since the last UC-MSCs infusion
Cumulative incidence of relapse of primary disease in 2 years
To investigate the safety characteristics, percentages will be calculated.
Measured: 2 years since the last UC-MSCs infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan TongJi Hospital, Wuhan Central Hospital
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Qiubai Li, Professor, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672420
- Sponsor's protocol ID
- UHCT22668
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase Ib/II Trial of the Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cells in Treatment-induced Myelosuppression in Patients With Hematologic Malignancies (USMYE Trial)
- ClinicalTrials.gov ID
- NCT05672420
- Acronym / sponsor ID
- UHCT22668
- Conditions
- Hematologic Neoplasms, Neutropenia, Anemia, Thrombocytopenia, Infections, Bleeding
- Keywords
- umbilical cord derived mesenchymal stem cells, treatment-induced myelosuppression, neutropenia, anemia, thrombocytopenia, infections, bleeding, hematologic malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 181 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan TongJi Hospital, Wuhan Central Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 5 Jan 2023 (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 purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies.
Detailed description
Despite the improved prognosis of patients with hematologic malignancies, almost all patients will experience severe myelosuppression induced by anti-cancer treatment, leading to a series of complications such as infection due to neutropenia, bleeding due to thrombocytopenia and/or impaired major organ function such as cardiac function due to anemia, which are the main reasons for dose reduction, dose interrruptions of anti-cancer treatment, failure of hematopoietic stem cell transplantation, and also patients' treatment-related death. It is of significant clinical importance and an urgent need to promote early recovery of myelosuppression and reduce risks of related complications as well as medical burdens. Umbilical cord derived mesenchymal stem cells (UC-MSCs), as a kind of stem cells with multipotential, can widely act on the functional cell units of bone marrow microenvironment and promote the repairment and regeneration of key cells such as hematopoietic stem cells, mesenchymal stem cells and endothelial cells, thus making it an ideal means for effectively promoting recovery of myelosuppression. Patients with hematologic malignancies and treatment-induced myelosuppression will be invited to participate in the Phase Ib/II study, to receive UC-MSCs intravenous infusion and follow-up visits of up to 2 years after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord derived mesenchymal stem cells (UC-MSCs) | Experimental | Biological: umbilical cord derived mesenchymal stem cellsIn the Phase Ib study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia, UC-MSCs will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, frequency of infusion will be preset with 3 escalation levels: frequency 1, frequency 2, frequency 3, total course of treatment: 2 weeks; In the Phase II study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia/primary hematological maligancies who are going to receive hematopoietic stem cell transplantation, UC-MSCs will be preset according to the recommended phase II dose (RP2D) from the Phase Ib study, total course of treatment: 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged between 18 and 75 years old;
- Either type of primary hematologic malignancies listed below:
- The participant or his/her legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with signed informed consent;
- Male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day anti-cancer therapy is initiated)
Key exclusion criteria (27 listed)
- Overt central nervous system manifestations of hematologic malignancies at diagnosis;
- Secondary hematological maligancies;
- Body mass index (BMI) of more than 30 kg/m^2;
- Myelosuppression induced by conditions other than anti-cancer therapy;
- Previous radiation therapy performed on sternum or pelvis;
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 derived mesenchymal stem cellsumbilical cord derived mesenchymal stem cells, intravenous infusion | Biological | umbilical cord derived mesenchymal stem cells (UC-MSCs) |
Primary outcome
Dose-limiting toxicities（DLT)
Time frame: 4 days after the last UC-MSCs dose, up to 12 days
During the DLT observation period, the subject has an adverse event that is reasonably related to UC-MSCs infusion (possibly, likely or definitely related).
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the day that the last UC-MSCs dose is used to up to 21 days
To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.
Maximum tolerated dose (MTD)
Time frame: From the day that the last UC-MSCs dose is used to up to 4 days
During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/3 in the dose group of at least 6 evaluble subjects of the study drug after the last UC-MSCs dose.
20 secondary outcomes
Time to absolute neutrophil count recovery
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of febrile neutropenia
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of febrile neutropenia
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of severe thrombocytopenia
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to severe thrombocytopenia recovery
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of severe anemia
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to severe anemia recovery
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of infetion
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of infetion
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Incidence of bleeding
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Duration of bleeding
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Application rate of blood transfusion
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Application rate of anti-infective agents
Time frame: From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days
Time to achievement of complete remission
Time frame: From enrollment to up to 28 days
Duration of complete remission
Time frame: From enrollment to maximun up to 2 years
Event free survival
Time frame: From enrollment to maximun up to 2 years
Overall survival
Time frame: From enrollment to maximun up to 2 years
Incidence of infusion reactions in 2 years
Time frame: 2 years since the last UC-MSCs infusion
Incidence of secondary tumor in 2 years
Time frame: 2 years since the last UC-MSCs infusion
Cumulative incidence of relapse of primary disease in 2 years
Time frame: 2 years since the last UC-MSCs infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Qiubai Li, Professor study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3 sites 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 derived mesenchymal stem cells in people with Hematologic Neoplasms and Neutropenia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites 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 16 inclusion and 27 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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 Qiubai Li, Professor ((027) 85726387, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities（DLT) (time frame: 4 days after the last UC-MSCs dose, up to 12 days). The study lists 3 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 5 Jan 2023.