"Evaluation of the Efficacy of Decidual Stromal Cells (DSCs) in the Prevention of Graft-versus-Host Disease (GvHD)"

Evaluation of the Safety and Efficacy of Repeated Administration of Decidual Stromal Cells (DSCs) in Prevention of Graft-versus-Host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation, Clinical Trial Phase I and II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240513061768N2

Enrollment

Registered

2025-09-28

Start date

2026-01-21

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-versus-Host Disease (GvHD). Graft-versus-host disease

Interventions

Intervention 1: Intervention group: Treatment will be performed with decidua stromal cells (DSCs) derived from the placenta and fetal membranes, produced in a cell manufacturing laboratory compliant w

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients at high risk of GvHD based on HLA mismatch severity or disease status (including patients with haploidentical or unrelated donors). 2. Ability to receive cell therapy. 3. Provision of written informed consent. 4. Patients of both genders. 5. Age between 18 and 70 years.

Exclusion criteria

Exclusion criteria: 1. Presence of active infection. 2. Severe underlying conditions that increase the risk of treatment. 3. History of allergy to components used in DSC infusion, such as albumin. 4. Active cardiac, renal, hepatic failure, or any chronic disease that may be affected by cell therapy. 5. Lack of sufficient awareness or cognitive capacity to provide informed consent.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety of DSC administration in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Timepoint: Safety: All patients will be monitored during infusion and at 2, 4, 6, 8, 12, and 24 hours post-infusion. In addition, patients will undergo periodic clinical evaluations by the attending physician to assess for treatment-related symptoms and potential toxicities. Method of measurement: Physical examination.;To evaluate the efficacy of DSC administration in preventingacute GvHD up to 12 months post-transplant, andchronic GvHD up to 24 months post-transplant. Timepoint: Effectiveness of DSCs administration in preventing acute GVHD over 12 months and chronic GVHD over 24 months post-transplant. Method of measurement: Physical examination.	—

Measure

Time frame

To evaluate the safety of DSC administration in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Timepoint: Safety: All patients will be monitored during infusion and at 2, 4, 6, 8, 12, and 24 hours post-infusion. In addition, patients will undergo periodic clinical evaluations by the attending physician to assess for treatment-related symptoms and potential toxicities. Method of measurement: Physical examination.;To evaluate the efficacy of DSC administration in preventingacute GvHD up to 12 months post-transplant, andchronic GvHD up to 24 months post-transplant. Timepoint: Effectiveness of DSCs administration in preventing acute GVHD over 12 months and chronic GVHD over 24 months post-transplant. Method of measurement: Physical examination.

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Secondary

Measure	Time frame
To evaluate GVHD-free, relapse-free survival (GRFS) in DSC-treated patients compared with the control group. Timepoint: Assessment of severe GVHD- and relapse-free survival (GRFS) in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: Physical examination.;To assess non-relapse mortality (NRM) in DSC-treated patients compared with the control group. Timepoint: Assessment of non-relapse mortality (NRM) in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: 12 and 24 months.;To evaluate overall survival (OS) in DSC-treated patients compared with the control group. Timepoint: Assessment of overall survival (OS) in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: Physical examination.;To assess the rate of relapse in DSC-treated patients compared with the control group. Timepoint: Assessment of relapse rates in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: Physical examination.	—

Measure

Time frame

To evaluate GVHD-free, relapse-free survival (GRFS) in DSC-treated patients compared with the control group. Timepoint: Assessment of severe GVHD- and relapse-free survival (GRFS) in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: Physical examination.;To assess non-relapse mortality (NRM) in DSC-treated patients compared with the control group. Timepoint: Assessment of non-relapse mortality (NRM) in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: 12 and 24 months.;To evaluate overall survival (OS) in DSC-treated patients compared with the control group. Timepoint: Assessment of overall survival (OS) in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: Physical examination.;To assess the rate of relapse in DSC-treated patients compared with the control group. Timepoint: Assessment of relapse rates in patients treated with DSCs compared to the control group at 12 and 24 months post-transplant. Method of measurement: Physical examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Sarvestani

Taskin Bio regeneration Company

m.sarvestani76@gmail.com+98 901 523 1548

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026