Stem cell therapy in knee osteoarthritis

General Information

Summary SCUlpTOR is a 24-month research study from the Institute of Bone and Joint Research (IBJR) at the University of Sydney, evaluating the efficacy and cost-effectiveness of stem cell injections compared with placebo in people with knee OA. Currently, the medical opinion about stem cell therapy for treating osteoarthritis remains highly controversial, given the considerable cost of treatment and very limited scientific evidence of efficacy and safety. Therefore, we aim to conduct this trial to ascertain whether or not intra-articular stem cell injections improve symptoms and slow disease progression in people with mild to moderate knee OA. The stem cells that we used was originally sourced from a healthy donor/master cell bank following standard manufacturing process and release tests to optimise safety and batch to batch reproducibility.
Clinical trials phase Phase 3
Start date (estimated) 2021-03-15
End date (estimated) 2025-12-31
Clinical feature
Label osteoarthritis
Link http://purl.obolibrary.org/obo/DOID_8398
Description An arthritis that has_material_basis_in worn out cartilage located_in joint.; Xref MGI.

Administrative Information

ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12620000870954
Other study identifiers
Name ACTRN12620000870954
Description Australian Newzealand Clinical Trials Registry (ANZCTR)
Name U1111-1234-4897
Description (Universal Trial Number (UTN)
Source weblink http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000870954
Public contact
Email sarah.robbins@sydney.edu.au
Public email sarah.robbins@sydney.edu.au
First name Sarah
Last name Robbins
Phone +61 02 9463 1855
City Sydney
Country
Australia
Address freetext Institute of Bone and Joint Research, Kolling Institute of Medical Research, The University of Sydney. Rheumatology Department, Lv 10 Kolling Building, Reserve Road, St Leonards, NSW 2065, Australia
Sponsors University of Sydney

Cells

Which differentiated cell type is used
Label mesenchymal stem cell
Link http://purl.obolibrary.org/obo/CL_0000134
Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.

Recruitment

Recruitment Status Recruiting
Estimated number of participants 440