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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03067870
Enrollment
100
Registered
2017-03-01
Start date
2016-11-30
Completion date
2022-02-28
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip, Osteoarthritis, Knee, RheumatoId Arthritis

Keywords

Stem cells, 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.

Interventions

BIOLOGICALStem Cell Transplantation

* Intravenous administration of autologous bone marrow derived stem cells for immunomodulation. * Transplantation of autologous bone marrow derived stem cells in joints.

Sponsors

Stem Cells Arabia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Pain Reduction measured by VAS scaling1 monthmeasured by VAS scaling

Secondary

MeasureTime frame
Evaluation of the Physical Activity measure by WOMAC scoring1 month
Evaluation the resurfacing of articular cartilage by MRI6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026