Health Condition 1: PCS- Health Condition 2: null- Prophylaxis of aGvHD after allogeneic Hematopoietic Stem Cell Transplantation
Conditions
Interventions
Intervention1: R- HSC-008: The IP R-HSC-008 contains expanded allogenic human MSCs derived from human umbilical cord tissue.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Reliance Life Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 10 to 55 years of age. 2. Subjects undergoing allo- HSCT 3. Matched donor graft should be a full house HLA match as decided by the PI. 4. Subjects diagnosed with aplastic anemia and considered for transplantation as a therapy. 5. Adequate liver & renal functions. The levels of SGOT/SGPT, serum bilirubin & serum Creatinine should be 6. Women of childbearing potential must have been using adequate birth control procedures; all women of childbearing potential must have had a negative pregnancy test prior to receiving the therapy 7. Subject / Legally Acceptable Representative (LAR) is able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
Exclusion criteria
Exclusion criteria: 1. Subject with inadequate cardiac function and pulmonary function 2. Subjects with bacterial, viral or fungal infection not being controlled with adequate treatment. 3. Subjects with HIV, HBsAg and HCV sero reactive. 4. Subject with uncontrolled diabetes (random blood sugar >300mg %). 5. Subjects has a known allergy to bovine or porcine products 6. Patient has any underlying or current medical condition that would interfere with the evaluation of the patient include uncontrolled infection, sepsis, organ failure etc. or any medical condition that has a high probability of causing death in less than 30 days. 7. Any other reason that the investigator/clinical supervisors may have for considering a case unsuitable for study. 8. Current participation in another study or prior participation in another study since last 3 months with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety of R-HSC-008 in aGvHD prevention after allo- HSCTTimepoint: Day 28, 60,100, 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the incidence of grade II-IV aGvHD up to day 100after matched related donor allo- HSCT when incorporating R-HSC-008 in the proposed aGvHD prophylaxis regimen 2. Evaluation of engraftment pattern in allo- HSCT upon incorporation of R-HSC-008 in the proposed aGvHD prophylaxis regimen 3. Evaluation of overall survival of subjectsTimepoint: Day 28, 60,100, 180 | — |
Countries
India
Contacts
Public ContactDr Prashant Pandya
Outcome results
None listed