Osteoarthritis stem cell therapy

Not Applicable

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN13337022
• Lead Sponsor: Specialty Hospital St. Catherine

Brief Summary

2017 results in https://pubmed.ncbi.nlm.nih.gov/29027984/ (added 22/10/2020) 2019 results in https://pubmed.ncbi.nlm.nih.gov/31187950/ (added 23/10/2020) 2019 24 month follow up results in https://pubmed.ncbi.nlm.nih.gov/31861180/ (added 23/10/2020) 2019 sub study in https://pubmed.ncbi.nlm.nih.gov/31234442/ (added 23/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-24
• Study Completion: 2018-01-18
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age 40-85
2. Knee osteoarthritis (radiological Kellgren and Lawrence grade II-IV)
3. Onset of symptoms for more than 6 months in the painful knee
4. Able to follow the instructions of the study
5. Signed an informed consent form

Exclusion Criteria

1. Age less than 40 years or more than 85 years
2. Chondromatosis or villonodular synovitis of the knee
3. Recent trauma (<3 month) of the symptomatic knee
4. Infectious joint disease
5. Malignancy
6. Patients on anticoagulant therapy with PT ( < 0,70) or suffering from thrombocytopenia and/or coagulation disorder
7. Hypersensitivity to local anaesthetic

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Pain in the knee is measured using the visual analogue scale (VAS) at the baseline, 3, 6 and 12 months<br> 2. Function of the knee is measured using Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, 3, 6 and 12 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Matrix synthesis in the cartilage layer (glycosaminoglycan content) delayed gadolinium enhanced MRI (dGEMRIC) imaging technique is applied at the baseline, 3, 6 and 12 months.<br> 2. Changes in IgG glycosylation associated with inflammatory processes analyses of IgG glycom from the blood plasma and synovial fluid (when available) is performed at baseline, 6 and 12 months<br> 3. Subchondral bone edema, morphology of cartilage and soft tissues is measured by MRI scans at baseline and at 3, 6 and 12 months<br>