Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases
NCT06888973 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-03-21
Summary
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.
Conditions
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus (SLE)
- Systemic Sclerosis
- Ankylosing Spondylitis (AS)
- Juvenile Idiopathic Arthritis
- Polymyositis/Dermatomyositis
Interventions
- BIOLOGICAL
-
Mesenchymal Stem Cells
allogeneic bone marrow-derived mesenchymal stem cells therapy
- OTHER
-
Placebo
0.9% Saline as placebo
Sponsors & Collaborators
-
Pak Emirates Military Hospital
collaborator OTHER -
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
lead OTHER_GOV
Principal Investigators
-
Memoona Haider, MBBS, FCPS · National University of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2025-02-01
- Completion
- 2026-02-01
Countries
- Pakistan
Study Locations
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