Transplantation of stem cells in knee joint osteoarthritis

Phase 2

• Conditions: Condition 1: Knee joint osteoarthritis. Condition 2: Knee joint osteoarthritis.; Primary gonarthrosis, bilateral; Other primary gonarthrosis Primary gonarthrosis: • NOS • unilateral

• Registration Number: IRCT201507061031N1
• Lead Sponsor: Royan Institute

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: 48

Inclusion Criteria

Inclusion Criteria: Patients in the range of 18 to 65 years old; Osteoarthritis diagnosed by MRI

Exclusion Criteria

Pregnancy or lactating; Positive tests for HIV, HCV, HBV; Active neurologic disorder; End organ damage; History/active malignancy; Uncontrolled endocrine disorder; Active respiratory disorder/reaction to sedation drugs; History of cancer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Function improvement. Timepoint: 3,6,12 and 30 months after transplantation. Method of measurement: WOMAC osteoarthritis index.;Pain density. Timepoint: 3,6,12 and 30 months after transplantation. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Joint function. Timepoint: 6,12 and 30 months after transplantation. Method of measurement: Physical examination, VAS, womac.;Allergic reactions. Timepoint: 3,6,12and 30 month after transplantation. Method of measurement: Physical examination.;Neoplastic changes. Timepoint: 6,12 and 30 months after transplantation. Method of measurement: MRI.;Cartilage thickness. Timepoint: 6,12 and 30 months after transplantation. Method of measurement: MRI.;Subchondral edema. Timepoint: 6,12 and 30 months after transplantation. Method of measurement: MRI.