Clinical trial NCT01873625: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Keywords: mesenchymal stem cells
osteoarthritis
arthritis rheumatoid
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: pain
timeFrame: 1month
measure: physical activity
timeFrame: 1month
measure: walking distance
timeFrame: 1month
Secondary outcomes:
measure: Imaging
timeFrame: 6months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of regenerative medicine department, head of Royan cell therapy center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Royan Institute,Department of regenerative medicine
name: Mohsen Emadedin, MD
role: STUDY_DIRECTOR
affiliation: President of rheumatologic association center of Iran
name: Farhad gharibdoost, MD
role: STUDY_DIRECTOR
affiliation: Royan Institute, Department of regenerative medicine
name: Soraya Shadmanfar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.