Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis

Resurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01873625

Enrollment

Registered

2013-06-10

Start date

2009-10-31

Completion date

2011-12-31

Last updated

2013-06-10

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

Conditions

Rheumatoid Arthritis

Keywords

mesenchymal stem cells, osteoarthritis, arthritis rheumatoid

Brief summary

Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.

Detailed description

In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A (control group) received only routine medical therapies and placebo injected into there knees.. Group B received mesenchymal stem cells in addition of routine medical therapy. Patients were categorized according to the following stimulation protocols: To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments and biochemical analysis with laboratory tests.

Interventions

BIOLOGICALmesenchymal cell transplantation

Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

BIOLOGICALplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Age 18 to 65 years 2. Body mass index (BMI) ≤30 kg/m2 3. The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before invitation

Exclusion criteria

1\. Response to routine treatment at last one year.

Design outcomes

Primary

Measure	Time frame	Description
pain	1month	Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.
physical activity	1month	evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.
walking distance	1month	Evaluation the walking distance after mesenchymal transplantation.

Secondary

Measure	Time frame	Description
Imaging	6months	Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026