Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03067870
• Date of registration: 25/02/2017
• Prospective Registration: No
• Primary sponsor: Stem Cells Arabia
• Public title: Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis
• Scientific title: Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis
• Date of first enrolment: November 2016
• Target sample size: 100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03067870
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Key inclusion & exclusion criteria

Inclusion Criteria:

- 17-75 years old

- The presence of osteoarthritis based on MRI and American Rheumatism Association
criteria since 6 months before treatment.

Exclusion Criteria:

- Subjects with addition major health condition/disease diagnoses

- Subjects that are pregnant or breastfeeding



Age minimum: 17 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

RheumatoId Arthritis

Osteoarthritis, Knee

Osteoarthritis, Hip

Intervention(s)

Biological: Stem Cell Transplantation

Primary Outcome(s)

Evaluation of Pain Reduction measured by VAS scaling [Time Frame: 1 month]

Secondary Outcome(s)

Evaluation of the Physical Activity measure by WOMAC scoring [Time Frame: 1 month]

Evaluation the resurfacing of articular cartilage by MRI [Time Frame: 6 months]

Secondary ID(s)

SCA-RA1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors