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Trial record 2 of 54 for:    stem cell arthritis AND bone marrow

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

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ClinicalTrials.gov Identifier: NCT01873625
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: mesenchymal cell transplantation Biological: placebo Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
Biological: placebo
Active Comparator: mesencymal stem cell
Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
Biological: mesenchymal cell transplantation
Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.




Primary Outcome Measures :
  1. pain [ Time Frame: 1month ]
    Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.

  2. physical activity [ Time Frame: 1month ]
    evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.

  3. walking distance [ Time Frame: 1month ]
    Evaluation the walking distance after mesenchymal transplantation.


Secondary Outcome Measures :
  1. Imaging [ Time Frame: 6months ]
    Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.



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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873625


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of regenerative medicine department, head of Royan cell therapy center
Study Director: Mohsen Emadedin, MD Royan Institute,Department of regenerative medicine
Study Director: Farhad gharibdoost, MD President of rheumatologic association center of Iran
Principal Investigator: Soraya Shadmanfar, MD Royan Institute, Department of regenerative medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01873625     History of Changes
Other Study ID Numbers: Royan-RA-001
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: August 2009
Keywords provided by Royan Institute:
mesenchymal stem cells
osteoarthritis
arthritis rheumatoid
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases