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

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

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Iran, Islamic Republic of

Royan Institute

Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Royan Institute

Investigators

• 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

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shadmanfar S, Labibzadeh N, Emadedin M, Jaroughi N, Azimian V, Mardpour S, Kakroodi FA, Bolurieh T, Hosseini SE, Chehrazi M, Niknejadi M, Baharvand H, Gharibdoost F, Aghdami N. Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7.

• Responsible Party: Royan Institute
• ClinicalTrials.gov Identifier: NCT01873625
• Other Study ID Numbers: Royan-RA-001
• First Posted: June 10, 2013
• 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:

Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases