A Phase 2 interventional study of Mesenchymal stem cell and Placebo in Osteoarthritis, sponsored by SCARM Institute, Tabriz, Iran. Withdrawn at 1 site in Iran, Islamic Republic of. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by SCARM Institute, Tabriz, Iran · Phase 2, Interventional, and Treatment
Osteoarthritis of the knee is one of the most common causes of disability among elderly. 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 (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis
This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale
Exclusion Criteria:
Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection
Biological: Mesenchymal stem cell
The patients who are in control group and underwent placebo injection
Biological: Placebo
intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation
Patients with knee joint osteoarthritis who underwent intra articular placebo injection
physical function improvement
Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection
Time frame: 2 weeks
Change in pain density
Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection
Time frame: 2 weeks
Joint swelling
Evaluation the joint swelling by physical examination after intra articular cell injection
Time frame: 3 months
Joint erythema
Evaluation the joint erythema by physical examination after cell injection
Time frame: 3 months
Deterioration of joint function
Evaluation the deterioration of joint function by physical examination after intra articular cell injection
Time frame: 3 months
Allergic reactions
Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection
Time frame: 3 months
Plan to share: No
This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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SCARM Institute, Tabriz, Iran