Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic Syndromes
Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat RA and RARS of MDS
2 other identifiers
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg on the subjects for refractory anemia (RA) and refractory anemia with ring sideroblast (RARS) of myelodysplastic syndromes (MDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 25, 2010
May 1, 2010
3 years
May 17, 2010
May 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
MDS clinical symptoms (mainly anemia symptoms)
Anemia symptoms will be mainly observed in every week after transplanting MSCs for one year.
1 year
A routine blood test
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.
1 year
Bone borrow cytomorphologic examination
Bone borrow cytomorphologic examination will be tested in every 3 months after transplanting MSCs for one year.
1 year
Secondary Outcomes (1)
Percentage of T regulatory cell population in peripheral blood
1 year
Study Arms (2)
Human umbilical cord-derived MSCs
EXPERIMENTALHuman umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated to apply in trimonthly for 2 cycle
cyclosporine A (CsA)
ACTIVE COMPARATORCsA at a dose of 5 mg CsA/kg
Interventions
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
Eligibility Criteria
You may qualify if:
- Patient age 18\~80 years old with plan to infuse MSCs.
- Histologically documented or cytologically confirmed diagnosis of MDS with WHO classification of MDS-RA and MDS-RARS.
- Patients must have an ECOG 0\~2.
- No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 mmol/L.
- No active severe viral or fungus infection.
- Each patient must sign written informed consent.
You may not qualify if:
- Psychiatric condition that would limit informed consent.
- HIV positive
- Positive Pregnancy Test
- Patient has enrolled another clinical trial study within last 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- National Natural Science Foundation of Chinacollaborator
Study Sites (1)
Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, 250033, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
cheng yun zheng, PhD
Department of Hematology of The 2nd Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 25, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 25, 2010
Record last verified: 2010-05