- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04692376
MSC for Treatment of cGVHD After Allo-HSCT
Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogenetic Hematopoietic Stem Cell Transplantation
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion.
Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Rekrytering
- Department of Hematology,Nanfang Hospital, Southern Medical University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- A patient age of 18-65 years
- Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Primary disease relapse
- Expected lifetime less than 3 months
- Patients with any conditions not suitable for the trial (investigators' decision)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: MSCs group
MSCs group refers to treatment with mesenchymal stem cells (1×10^6 cells/kg, intravenously) weekly for 8 doses.
Besides, glucocorticoids and cyclosporine (CsA) will be used for treatment concurrently.
|
Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 mins) weekly.
MSCs will be administrated for 8 doses.
Glucocorticoids (i.e.
Methylprednisolone) will be used with an initial dose of 1mg/kg.
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA.
The targeted concentration is 200-300 ng/Ml.
|
Aktiv komparator: Control group
Glucocorticoids and CsA will be used for treatment.
|
Glucocorticoids (i.e.
Methylprednisolone) will be used with an initial dose of 1mg/kg.
Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA.
The targeted concentration is 200-300 ng/Ml.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
ORR
Tidsram: 12 weeks after the first dose of MSCs
|
Overall response rate (ORR)includes complete response (CR) and part response (PR).
|
12 weeks after the first dose of MSCs
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
OS
Tidsram: 1 year after the first dose of MSCs
|
Overall survival (OS)
|
1 year after the first dose of MSCs
|
DFS
Tidsram: 1 year after the first dose of MSCs
|
Disease-free survival (DFS)
|
1 year after the first dose of MSCs
|
Response rate
Tidsram: 4 weeks after the first dose of MSCs
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4 weeks after the first dose of MSCs
|
|
EBV DNA-emia
Tidsram: 1 year after the first dose of MSCs
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EBV DNA-emia refers to detection of EBV DNA in peripheral blood via PCR.
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1 year after the first dose of MSCs
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CMV DNA-emia
Tidsram: 1 year after the first dose of MSCs
|
CMV DNA-emia refers to detection of CMV DNA in peripheral blood via PCR.
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1 year after the first dose of MSCs
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PGF
Tidsram: 1 year after the first dose of MSCs
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Poor graft function (PGF) refers to a slow or incomplete recovery of blood cell counts (ANC ≤0.5x10^9/L and PLT ≤20x10^9/L) by +28 days after allo-HSCT or a fall in blood cell counts to levels fulfilling the diagnostic criteria for PGF after successful and prompt hematopoietic engraftment.
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1 year after the first dose of MSCs
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Qi-fa Liu, MD, Nanfang Hospital of Southern Medical University
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Graft vs Host Disease
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antireumatiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Dermatologiska medel
- Antifungala medel
- Calcineurin-hämmare
- Cyklosporin
- Cyklosporiner
- Glukokortikoider
Andra studie-ID-nummer
- MSC-cGVHD-2020
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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