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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

mesenchymal cell transplantation

placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring mesenchymal stem cells, osteoarthritis, arthritis rheumatoid

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 to 65 years
Body mass index (BMI) ≤30 kg/m2
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.

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

mesencymal stem cell

Arm Description

Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

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

Outcomes

Primary Outcome Measures

pain

Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.

physical activity

evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.

walking distance

Evaluation the walking distance after mesenchymal transplantation.

Secondary Outcome Measures

Imaging

Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.

Full Information

NCT ID

NCT01873625

First Posted

June 5, 2013

Last Updated

June 7, 2013

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01873625

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

mesenchymal stem cells, osteoarthritis, arthritis rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Arm Title

mesencymal stem cell

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

mesenchymal cell transplantation

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

pain

Description

Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.

Time Frame

1month

Title

physical activity

Description

evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.

Time Frame

1month

Title

walking distance

Description

Evaluation the walking distance after mesenchymal transplantation.

Time Frame

1month

Secondary Outcome Measure Information:

Title

Imaging

Description

Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.

Time Frame

6months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 to 65 years Body mass index (BMI) ≤30 kg/m2 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.

Overall Study Officials: