Clinical trial NCT06469411: Effect of PMSCs and Their Secretome for the Treatment of GvHD
Official title: The Effect MSCs Derived From the Placenta and Their Secretome for the Treatment of GvHD: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GVHD
Keywords: Bone marrow
Mesenchymal stem cell
Secretome
Severe Graft-versus-host disease
Lead sponsor: Tabriz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: SCARM Institute, Tabriz, Iran
First posted: 2024-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a safety, feasibility, and efficacy trial that was conducted on eligible GvHD patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the Iranian Trial Registration Center. During the phone call, while stating the title and objectives of the study, the entry and exclusion criteria were checked. If they are eligible, they were asked to attend the Ghazi Hospital if they wish to participate in the study. In the face-to-face meeting, the objectives of the research were fully explained and the study criteria were re-examined. The written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics, medical characteristics, appetite questionnaire, 24-hour food record (Food record), and family members. At the beginning of the study, 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells. 200 men with GvHD were randomly assigned using random block method using blocks of 4 and 6 and RAS (Random Allocation Software) and allocation ratio 1:1 to two groups receiving intravenous secretome with The first protocol (30 people) and receiving the mesenchymal stem cells secretome of the second protocol (30 people) were allocated and they received the skin spray for 1 year. Participants in the first protocol group at the beginning of the study, day 3, end of the week, the end of the second week, and the end of the month 5 times and in the second protocol group at the beginning of the study, skin spray were done. The secretome of both groups was the same.

Eligibility criteria: Inclusion Criteria:

* Patients with acute GvHD with fever and requiring hospitalization

Exclusion Criteria:

* Patients with sepsis

Primary outcomes:
measure: Liver involvement
timeFrame: At the beginning of the study and 6 weeks after the intervention
measure: Intestine condition
timeFrame: At the beginning of the study and 6 weeks after the intervention
measure: Skin rash
timeFrame: At the beginning of the study and 6 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Abolfazl Barzegari
state: East Azerbaijan
Study officials:
affiliation: Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran
name: Hossein Ghasemi Moghadam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
name: Sepideh Zununi Vahed, PhD
role: STUDY_DIRECTOR
affiliation: Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
name: Babak Nejati, MD
role: STUDY_DIRECTOR
affiliation: Université Sorbonne Paris Nord, INSERM U1148, Laboratory for Vascular Translational Science, Cardiovascular Bioengineering, 99 Av. Jean-Baptiste Clément 93430 Villetaneuse, France
name: Graciela Pavon-Djavid, PhD
role: STUDY_CHAIR
References: