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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 1, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
RheumatoId Arthritis Osteoarthritis, Knee Osteoarthritis, Hip Biological: Stem Cell Transplantation Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Stem Cells
Autologous bone marrow-derived stem cell transplantation.
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.

Outcome Measures

Primary Outcome Measures :
  1. Evaluation of Pain Reduction measured by VAS scaling [ Time Frame: 1 month ]
    measured by VAS scaling

Secondary Outcome Measures :
  1. Evaluation of the Physical Activity measure by WOMAC scoring [ Time Frame: 1 month ]
  2. Evaluation the resurfacing of articular cartilage by MRI [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
More Information

Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT03067870     History of Changes
Other Study ID Numbers: SCA-RA1
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Stem Cells Arabia:
Stem cells
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis, Knee
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases