Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases

Sponsor
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
Study ID
NCT06888973
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesenchymal Stem Cells — BIOLOGICAL
    allogeneic bone marrow-derived mesenchymal stem cells therapy
  • Placebo — OTHER
    0.9% Saline as placebo

Study Details

The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat autoimmune diseases, when compared to normal saline (given to placebo group). The primary outcome measures will be clinical improvement based on the respective disease specific clinical scores, normalization of T-lymphocyte subsets and \> 50% reduction in disease specific antibody titres. The study will also document the type and frequency of any adverse event or side effects, reported by or seen in any of the trial participants. Patients in treatment group will receive single session of MSC therapy and placebo group will receive 0.9% saline solution. The participants will be followed at 3 and 6 months.

Key Dates

Start date
Feb 1, 2025
Status verified
Jan 2025
Primary completion
Feb 1, 2025
Completion
Feb 1, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    MSC therapy group
  • Placebo Comparator: Placebo group
    Placebo (0.9% saline)

Primary Outcome Measure

Primary Outcome Measures for RA [ Time Frame: Day 0, Weeks 12, 24, 48 ]

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