- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01129739
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Chengyun Zheng, PhD
- Telefonnummer: +86-531-85875635
- E-mail: chengyun.zheng@ki.se
Studiesteder
-
-
Shandong
-
Jinan, Shandong, Kina, 250033
- Rekruttering
- Department of Hematology of the 2nd Hospital of Shandong University
-
Kontakt:
- Chengyun Zheng, PhD
- Telefonnummer: +86-531-85875635
- E-mail: chengyun.zheng@ki.se
-
Ledende efterforsker:
- chengyun zheng, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Psychiatric condition that would limit informed consent.
- HIV positive
- Positive Pregnancy Test
- Patient has enrolled another clinical trial study within last 4 weeks.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
|
Aktiv komparator: cyclosporine A (CsA)
CsA at a dose of 5 mg CsA/kg
|
CsA 5mg/kg po for 6 months
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
MDS clinical symptoms (mainly anemia symptoms)
Tidsramme: 1 year
|
Anemia symptoms will be mainly observed in every week after transplanting MSCs for one year.
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1 year
|
A routine blood test
Tidsramme: 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.
|
1 year
|
Bone borrow cytomorphologic examination
Tidsramme: 1 year
|
Bone borrow cytomorphologic examination will be tested in every 3 months after transplanting MSCs for one year.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of T regulatory cell population in peripheral blood
Tidsramme: 1 year
|
Percentage of T regulatory cell population in peripheral blood will be tested in every 3 months after transplanting MSCs for one year.
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: cheng yun zheng, PhD, Department of Hematology of the 2nd Hospital of Shandong University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Syndrom
- Myelodysplastiske syndromer
- Præleukæmi
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Enzymhæmmere
- Antirheumatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Dermatologiske midler
- Antifungale midler
- Calcineurin-hæmmere
- Cyclosporin
- Cyclosporiner
Andre undersøgelses-id-numre
- CZheng
- No. 30670903 (Anden identifikator: National Natural Science Foundation of China)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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