- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00749164
Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment (MSCGVHD)
Allogeneic Mesenchymal Stem Cell Infusion for Treatment Of Steroid Resistant GVHD
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Prof. Igor B. Resnick, MD, PhD, DSci
- Phone Number: 972-2-6778353
- Email: gashka@hadassah.org.il
Study Contact Backup
- Name: Dr. Polina Stepensky, MD
- Phone Number: 972-2-6777408
- Email: polina@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Hadassah University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
1. Informed consent. 2. Any patient that has undergone allogeneic stem cell transplantation with steroid refractory grades II-IV acute GvHD either occurring post transplant, or induced by donor lymphocyte infusions (DLI) or T-cell add back. A positive biopsy for GvHD is not required if clinical signs and symptoms are characteristic for GvHD and other etiologies are excluded.
3. Patient received best known therapy for GvHD including: i. Patients must receive cyclosporine A (trough level 150-300 ng/ml) or tacrolimus (trough level 5-15 ng/ml).
ii. In addition, steroids must have been given, for instance prednisolone ≥2 mg/kg/day (or equivalent doses of methylprednisolone, etc.) for at least 72h in case of progressive acute GvHD, 5 days non progressive acute GvHD.
iii. Despite this treatment, the patient has unresponsive GvHD after 5 days or progressive acute GvHD after 72 hours. If single organ acute GvHD grade II from gut or liver, either progression from single organ or addition of one or two more organs; e.g., if the patient has grade II acute GvHD of the skin, GvHD is more intense and more widespread, or GvHD also includes liver and/or gut.
iv. Patients with steroid refractory GvHD fulfilling the requirements mentioned in a) - c) may be treated with second line therapy, e.g., MMF, serotherapy, ECP, change of CsA for tacrolimus or vice versa, etc. Failure to respond to additional treatment similar to what is described for steroids in c) is necessary before enrolment in this study.
v. Termination of all GvHD medications other than cyclosporine/tacrolimus/MMF and prednisolone is strongly encouraged.
Exclusion criteria
- Patients with poor performance, not expected to survive 5 days.
- Patients with a history of hypersensitivity to penicillin and/or gentamycine
- Poor compliance.
Donor inclusion criteria:
- MSC donor must be HIV, HB-s antigen, anti HBc and anti HCV negative.
- First choice original HSC donor HLA-identical sibling donor.
- Second choice mismatched related or unrelated donor (for instance MSC frozen and left over from another patient).
- Third choice or emergency pre-expanded third party umbilical cord/placenta derived MSC.
Donor exclusion criteria:
- Donor more than 65 years of age, or unhealthy.
- Donor who is positive for HIV, hepatitis Bs antigen, HB-s, anti-HBc and anti HCV negative.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GVHD re-staging and/or GVHD mortality ,side effects
Time Frame: within the first 30 days (plus or minus 3 days) after MSC transplantation
|
within the first 30 days (plus or minus 3 days) after MSC transplantation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof. Igor B Resnick, MD, PhD, DSci, Hadassah University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBR-0137-08-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Graft-Versus-Host Disease
-
University of LiegeTerminatedChronic Graft-Versus-Host Disease | Acute Graft-Versus-Host Disease | Steroid Refractory Graft-Versus-Host DiseaseBelgium
-
Jazz PharmaceuticalsCompletedAcute-graft-versus-host Disease | Graft-versus-host DiseaseUnited States, Belgium, United Kingdom, Greece, Germany, Spain, France, Italy, Austria, Canada, Bulgaria, Croatia, Poland, Portugal
-
Mesoblast, Inc.Quintiles, Inc.CompletedGrade B Acute Graft Versus Host Disease | Grade C Acute Graft Versus Host Disease | Grade D Acute Graft Versus Host DiseaseUnited States
-
Grupo Espanol de trasplantes hematopoyeticos y...CompletedChronic Graft-Versus-Host DiseaseSpain
-
National Cancer Institute (NCI)TerminatedGraft vs Host Disease | Graft-Versus-Host Disease | Chronic Graft vs. Host DiseaseUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteNovartisCompletedGraft-Versus-Host DiseaseUnited States
-
M.D. Anderson Cancer CenterCompleted
-
John LevineCompletedGVHD | Low Risk Acute Graft-versus-host Disease | Graft-versus-host-diseaseUnited States
-
AltruBio Inc.CompletedSteroid-refractory Acute Graft-versus-Host Disease | Treatment-refractory Acute Graft-versus-Host DiseaseUnited States
-
Jonsson Comprehensive Cancer CenterWithdrawnAcute Graft Versus Host Disease | Gastrointestinal Tract Acute Graft Versus Host Disease | Severe Gastrointestinal Tract Acute Graft Versus Host Disease | Steroid Resistant Gastrointestinal Tract Acute Graft Versus Host DiseaseUnited States
Clinical Trials on MSC transplantation
-
Royan InstituteUnknownKienböck's DiseaseIran, Islamic Republic of
-
Brainstorm-Cell TherapeuticsHadassah Medical OrganizationCompletedAmyotrophic Lateral SclerosisIsrael
-
Shanghai Life Science & TechnologyShanghai Jiao Tong University Affiliated Sixth People's HospitalNot yet recruitingAcute Myocardial Infarction | Left Ventricular DysfunctionChina
-
University Medical Centre LjubljanaSlovenian Research AgencyTerminated
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...UnknownSystemic Lupus ErythematosusChina
-
R.J.H. CustersZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting
-
Air Force Military Medical University, ChinaFudan University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsUnknownEnd Stage Liver Disease | Liver CirrhosisChina
-
Vinmec Research Institute of Stem Cell and Gene...Number 2 Children's Hospital, Ho Chi Minh CityUnknownPrimary Biliary CirrhosisVietnam
-
Hadassah Medical OrganizationCompleted
-
Fu-Sheng WangUnknownHuman Immunodeficiency Virus | Disorder of Immune ReconstitutionChina