Status:
COMPLETED
UCMSCs as Front-line Approach of Treatment for Patients With aGVHD
Lead Sponsor:
Cytopeutics Sdn. Bhd.
Collaborating Sponsors:
Universiti Tunku Abdul Rahman
Conditions:
Acute-graft-versus-host Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: Graft-versus-host disease (GVHD) is a devastating complication following allogeneic hematopoietic stem cell transplantation (HSCT) mediated by stimulation of antigen presenting cells (APCs...
Eligibility Criteria
Inclusion
- Patient age 16 and above
- Patient who has undergone an allogeneic haematopoietic stem cell transplantation (HSCT) receiving allograft either from HLA-matched related donor (MRD), HLA-matched unrelated donor (MUD), Unrelated Cord Blood (UCB) or Haploidentical donor and developed grade II-IV acute graft versus host disease (acute GVHD) involving the skin, GI tract and/or liver based on 1994 Consensus Conference on Acute GVHD Grading
- Patient and/or parent(s) or legal guardian(s) and assent form signed informed consent. Assent form will be obtained for patients aged less than 18 years. Investigators will obtain the permission of the parents or guardians for the participation of the minor in the research, and to solicit assent from the minor
Exclusion
- Patient who has enrolled in another investigational drug trial or stem cell related trial or has completed the aforesaid within (3) months
- Patient with HIV or syphilis (Patient should be screened for HIV and VDRL up to 6 months prior to study start)
- Patient with Hepatitis B (HBV) or Hepatitis C (HCV). All patients must be screened for HBV and HCV up to 6 months prior to study start using the routine hepatitis virus laboratory. Patients who are positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients who are positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA
- Patient has creatinine clearance of ≤50mL/min or creatinine is ≥200 µmol/L
- Patient had undergone or on other immune-modulatory treatments such as interferon or Thalidomide over the last 12 months
- Patient with progressive underlying disease or not in complete remission (CR) at the time of transplant
- Any other severe co-morbidities which the doctor deems as a contraindication to cell therapy
- Adults under law protection or without ability to consent
- The patient has previous history or on-going psychiatric illness
- Patient has received an HSCT transplant for a solid tumor disease
- Patient has a known hypersensitivity to dimethyl sulfoxide (DMSO)
- Patient is a female who is pregnant, lactating, or is planning a pregnancy during study participation, or in the follow-up period
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03847844
Start Date
February 1 2019
End Date
August 31 2023
Last Update
January 2 2026
Active Locations (1)
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1
Hospital Ampang
Ampang, Selangor, Malaysia, 68000