Evaluation of efficacy of treatment with stem cells (SCs) and platelet-rich plasma (PRP) in patients with knee arthrosis

Not Applicable

• Conditions: Knee Osteoarthritis.; Primary gonarthrosis, bilateral

• Registration Number: IRCT2012080510507N1
• Lead Sponsor: Immunology Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

INCLUSION CRITERIA: Female or male patient with knee osteoarthritis based on the ACR criteria and knee radiography; Grade 2 or 3 osteoarthritis according to Kellgren and Lawrence grading scale; 45 < Patient’s Age< 75; Signed informed consent; No consumption of glucocorticoids, anti-inflammatory and immunomodulatory medications one week prior to the treatment; No history of previous participating in clinical trials on treatment of osteoarthritis; No intra-articular injection of hyaluronic acid in the past 6 months

EXCLUSION CRITERIA: Secondary osteoarthritis; Concurrent connective tissue disorder; Active neurological disease; Severe cardiac disease; Debilitating respiratory disease requiring constant treatment; Any endocrinopathy; Malignancies; Current infectious disease; Psychologic diseases (especially major depression) requiring treatment with antidepressants or related medications; Being under treatment with immunosuppressive or cytotoxic medications; Being under constant treatment with antithrombotic medications; History of allergy to biologic products; Hb < 11 g/dL; Plt < 120*103/µ

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morphological characteristics of of articular cartilage. Timepoint: Before intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: MRI Osteoarthritis Knee Score (MOAKS).;Pain. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Pain Numerical Scale Rating.;Symptoms and function of the affected knee. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Range of motion. Timepoint: Before intervention, 1 month post-intervention, 3 months post-intervention, 6 months post-intervention, 12 months post-intervention. Method of measurement: Angle with protractor.