We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 5 of 6 for:    Saved Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01873625
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
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.

Layout table for study information
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Layout table for location information
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Layout table for investigator information
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):
Layout table for additonal information
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01873625    
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
arthritis rheumatoid
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases