Clinical trial
The Effect MSCs Derived From the Placenta and Their Secretome for the Treatment of GvHD: A Randomized Clinical Trial
Name
IRCT20201108049311N7
Description
In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-06-30
Trial end
2024-01-30
Status
Completed
Phase
Early phase I
Treatment
Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)
Patients in the intervention arm received 6 doses of secretome of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) 4 cc dissolved in albumin 20% every week for 6 weeks
Arms:
Intervention group
4 cc distilled water dissolved in albumin 20%
Patients in the control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks
Arms:
Control group
Size
60
Primary endpoint
Liver involvement
At the beginning of the study and 6 weeks after the intervention
Intestine condition
At the beginning of the study and 6 weeks after the intervention
Skin rash
At the beginning of the study and 6 weeks after the intervention
Eligibility criteria
Inclusion Criteria:
* Patients with acute GvHD with fever and requiring hospitalization
Exclusion Criteria:
* Patients with sepsis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this clinical trial study, 60 patients with GvHD, who were referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 groups of 30 people, and the intervention and control groups received secretome and distilled water by injection, respectively. The method of blinding was tripleblinded and all the names and personal information of the patients was coded at the time of data collection and remain completely confidential.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'This study was a triple-blinded study. In this way, the doctor introduced the patients to receive secretome/distilled water and was not aware of the grouping. Participating volunteers did not know about receiving secretome, distilled water, or other drugs. Secretome and distilled water were placed in similar and coded vials. In addition, the placebo (distilled water) was identical in appearance (shape and color), taste, and smell with secretome. In addition, due to the coding of patients and the lack of clarity in the grouping of patients, the data analyzer were be also blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-06-21
1 organization
1 product
1 indication
Organization
Tabriz University of Medical SciencesIndication
Graft-versus-host disease