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Status unknownNCT03067870Updated Mar 17, 2020

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

A Phase 1 interventional study of Stem Cell Transplantation in RheumatoId Arthritis, Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Stem Cells Arabia. Status unknown. Open to participants aged 17 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Stem Cells Arabia · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
17 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • RheumatoId Arthritis
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip

Keywords

  • Stem cells
  • Rheumatoid arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Stem Cells Arabia is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • Subjects with addition major health condition/disease diagnoses
  • Subjects that are pregnant or breastfeeding
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Stem Cells

    Autologous bone marrow-derived stem cell transplantation.

    Biological: Stem Cell Transplantation

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.

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What researchers measure

Primary outcomes

  1. Evaluation of Pain Reduction measured by VAS scaling

    measured by VAS scaling

    Time frame: 1 month

Secondary outcomes

  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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03067870
Lead sponsor
Stem Cells Arabia
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Nov 2016
Primary completion
Dec 2021 (estimated)
Completion
Feb 2022 (estimated)
Last update
Mar 17, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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