Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT03067870|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|RheumatoId Arthritis Osteoarthritis, Knee Osteoarthritis, Hip||Biological: Stem Cell Transplantation||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||February 2022|
Experimental: Stem Cells
Autologous bone marrow-derived stem cell transplantation.
Biological: Stem Cell Transplantation
- Evaluation of Pain Reduction measured by VAS scaling [ Time Frame: 1 month ]measured by VAS scaling
- 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 ]