Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Nov 2016
Longer than P75 for phase_1 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMarch 17, 2020
March 1, 2020
5.1 years
February 25, 2017
March 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Pain Reduction measured by VAS scaling
measured by VAS scaling
1 month
Secondary Outcomes (2)
Evaluation of the Physical Activity measure by WOMAC scoring
1 month
Evaluation the resurfacing of articular cartilage by MRI
6 months
Study Arms (1)
Stem Cells
EXPERIMENTALAutologous bone marrow-derived stem cell transplantation.
Interventions
* Intravenous administration of autologous bone marrow derived stem cells for immunomodulation. * Transplantation of autologous bone marrow derived stem cells in joints.
Eligibility Criteria
You may qualify if:
- years old
- The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before treatment.
You may not qualify if:
- Subjects with addition major health condition/disease diagnoses
- Subjects that are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2017
First Posted
March 1, 2017
Study Start
November 1, 2016
Primary Completion
December 1, 2021
Study Completion
February 1, 2022
Last Updated
March 17, 2020
Record last verified: 2020-03