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

• ClinicalTrials.gov Identifier: NCT03067870
• Recruitment Status: Active, not recruiting
• First Posted: March 1, 2017
• Last Update Posted: June 5, 2018
• Sponsor: Stem Cells Arabia
• Information provided by (Responsible Party): Stem Cells Arabia

Tracking Information

• First Submitted Date: February 25, 2017
• First Posted Date: March 1, 2017
• Last Update Posted Date: June 5, 2018
• Study Start Date: November 2016
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2017)

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

measured by VAS scaling

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03067870 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 28, 2017)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis
• Official Title: Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• RheumatoId Arthritis
• Osteoarthritis, Knee
• Osteoarthritis, Hip

Intervention

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.

Study Arms

Experimental: Stem Cells

Autologous bone marrow-derived stem cell transplantation.

Intervention: Biological: Stem Cell Transplantation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 28, 2017): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2020
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 17 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03067870
• Other Study ID Numbers: SCA-RA1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Stem Cells Arabia
• Study Sponsor: Stem Cells Arabia
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Stem Cells Arabia
• Verification Date: June 2018