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

Phase 1

• Conditions: RheumatoId Arthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Interventions: Biological: Stem Cell Transplantation

• Registration Number: NCT03067870
• Lead Sponsor: Stem Cells Arabia

Brief Summary

Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis ultimately results in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has anti-inflammatory and regenerative effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC transplantation in treatment of rheumatoid arthritis.

Detailed Description

Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects joints. It typically results in swollen and painful joints. Pain and stiffness often worsen after rest. Most frequently, the wrist and hands are involved, with the same joints typically involved on both sides of the body. RA affects between 0.5-1% of adults in the developed world with between 5-50 per 100,000 people newly developing the disease each year. Onset is most frequent during middle age and women are affected 2.5 times as frequently as men. The goal of treatment is to reduce pain, decrease inflammation, and improve a person's overall functioning and quality of life.

Herein, the investigators study the safety and efficacy of the immunomodulatory effects of bone marrow-derived stem cells administered intravenously and the regenerative and repair potential of bone marrow-derived stem cells transplanted into the joints of patients with RA.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-02-25
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-15
• Last Update Posted: 2020-03-17
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cells	Stem Cell Transplantation	Autologous bone marrow-derived stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
Evaluation of Pain Reduction measured by VAS scaling	1 month	measured by VAS scaling

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Physical Activity measure by WOMAC scoring	1 month
Evaluation the resurfacing of articular cartilage by MRI	6 months