Intra-articular mesenchymal stem cell injections following arthroscopic microfracture versus arthroscopic microfracture alone for knee cartilage defects: a pilot randomised controlled trial

Phase 2

• Conditions: Knee cartilage defect; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12614000812695
• Lead Sponsor: Magellan Stem Cells

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Aged between 18 – 50 (inclusive). As isolated full thickness chondral defects are often traumatic in nature it is likely that this age restriction represents the majority of patients who undergo microfracture.
2.Pre-operative radiological diagnosis of an isolated full thickness knee cartilage defect of the medial or lateral femoral condyle
3.Planned arthroscopic microfracture/osteoplasty
4.Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors.
5.No plans at the time of enrolment to undergo surgery in the following three months. This criterion is aimed at avoiding co-interventions that may confound the results of the study. While involvement in the project will not strictly prevent participants from undertaking such interventions if required, we will exclude volunteers who already have such procedures scheduled

Exclusion Criteria

1.Pregnancy (accepted contra-indication as no safety data on this population).
2.Have other causes of their knee symptoms suspected to be due to serious pathology such as tumour or referral from the hip or lumbar spine. These conditions are not under investigation within the current project;
3.Blood disorder (accepted contra-indication as no safety data on this population)
4.MRI confirmed displaced meniscial tear.
5.MRI confirmed Grade II-IV degenerative osteoarthritis
6.History of cancer
7.History of atypical chronic pain syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified