Evaluation of mesenchymal stem cells in the treatment of knee osteoarthritis – prospective case series data collectio

Phase 2

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12615000258550
• Lead Sponsor: Magellan Stem Cells

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria :
1.Radiological diagnosis of knee osteoarthritis using the American College of Rheumatology criteria (Altman, 1986).
2.Primary OA treatment already undertaken defined as: analgesia/anti-inflammatory medication, supplements approved by the treating clinician (eg glucosamine sulphate), an attempted exercise program prescribed by a physiotherapist or medical practitioner for at least 8 weeks (Petrella 2000), weight loss and nutritional management as prescribed by a dietitian or medical practitioner for at least 8 weeks, and biomechanical management including bracing if appropriate as prescribed by a physiotherapist, podiatrist or medical practitioner. Autologous MSC is an invasive treatment and guidelines recommend trialling conservative measures as the first line of treatment in OA (Thompson, Gordon et al. 2009).
3.Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. This is required as no funding is available for translation or interpreters, and the outcome questionnaires to be used have only been validated in English language.

Exclusion Criteria

Exclusion Criteria:
1.Age <18yrs. OA does not commonly occur in people under 18.
2.Pregnancy (accepted contra-indication as no safety data on this population).
3.Breastfeeding (accepted contra-indication as no safety data on this population).
4.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.
5.Blood disorder (accepted contra-indication as no safety data on this population)
6.Anti-coagulant therapy that cannot safely be ceased.
7.History of cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified