Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic Syndromes
|ClinicalTrials.gov Identifier: NCT01129739|
Recruitment Status : Unknown
Verified May 2010 by Shandong University.
Recruitment status was: Recruiting
First Posted : May 25, 2010
Last Update Posted : May 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Other: Human umbilical cord-derived MSCs Other: cyclosporine A (CsA)||Phase 2|
Myelodysplastic syndromes are bone marrow stem cell disorders resulting in disorderly and ineffective hematopoiesis. MDS is characterized by variable degrees of cytopenias (anemia, neutropenia, and thrombocytopenia ) and risk of transformation to leukemia.
To date treatment of MDS is unsatisfactory: chemotherapy has a limited role in the management of leukemic progression; autologous stem cell transplantation does not prolong relapse-free survival and stem cell transplantation is poorly tolerated in older individuals. Some MDS patients have been shown to respond to a wide variety of immunosuppressive agents ranging from corticosteroids to CsA and antithymocyte globulin (ATG). However, the overall response rate is less than 30%. In fact, few treatments appear to change the natural history of MDS.
The management of MDS patients therefore remains to be improved. Human MSCs isolated from Wharton's jelly of the umbilical cord/placenta have been shown to have immunosuppressive, stimulating hematopoiesis and tissue repairing properties. This study will evaluate the safety and effectiveness of MSC transplant in the MDS patients.
This study will last about 3 years. Participants will be randomly assigned to receive either MSC transplant (Group 1) or CsA therapy alone (Group 2). Patients will undergo MSC transplant at the start of the study (defined as Day 0). After 3 months, patients will receive the second MSC transplantation when one responds well to the treatment. After 3, 6 and 12 months from the first transplantation, patients will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat RA and RARS of MDS|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||May 2013|
Experimental: Human umbilical cord-derived MSCs
Human umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated to apply in trimonthly for 2 cycle
Other: Human umbilical cord-derived MSCs
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
Active Comparator: cyclosporine A (CsA)
CsA at a dose of 5 mg CsA/kg
Other: cyclosporine A (CsA)
CsA 5mg/kg po for 6 months
- MDS clinical symptoms (mainly anemia symptoms) [ Time Frame: 1 year ]Anemia symptoms will be mainly observed in every week after transplanting MSCs for one year.
- A routine blood test [ Time Frame: 1 year ]A routine blood test, which contains WBC, Neu, RBC, Hb and PLT, will be mainly tested in every month after transplanting MSCs for one year.
- Bone borrow cytomorphologic examination [ Time Frame: 1 year ]Bone borrow cytomorphologic examination will be tested in every 3 months after transplanting MSCs for one year.
- Percentage of T regulatory cell population in peripheral blood [ Time Frame: 1 year ]Percentage of T regulatory cell population in peripheral blood will be tested in every 3 months after transplanting MSCs for one year.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129739
|Contact: chengyun zheng, PhDemail@example.com|
|Department of Hematology of the 2nd Hospital of Shandong University||Recruiting|
|Jinan, Shandong, China, 250033|
|Contact: Chengyun Zheng, PhD +86-531-85875635 firstname.lastname@example.org|
|Principal Investigator: chengyun zheng, PhD|
|Principal Investigator:||cheng yun zheng, PhD||Department of Hematology of The 2nd Hospital of Shandong University|