NCT03067870

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

Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stem Cells Arabia · Academic / Other
• Sex: All
• Age: 17 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• RheumatoId Arthritis
• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
BIOLOGICAL	Stem Cell Transplantation	* Intravenous administration of autologous bone marrow derived stem cells for immunomodulation. * Transplantation of autologous bone marrow derived stem cells in joints.

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-12-01
• Completion: 2022-02-01
• First posted: 2017-03-01
• Last updated: 2020-03-17