Osteoarthritis Clinical Trial
Official title:
Investigating the Potential for Musculoskeletal Tissues and Cells Isolated From Juvenile Patients in the Development of Novel Therapies for Cartilage and Bone Injury and Osteoarthritis
The goal of this observational study is to analyse the cartilage and bone forming potential of cells isolated from the tissues of patients undergoing surgery for the treatment of polydactyly, hip dislocation and from other bio-banked cartilage tissues. The main question it aims to answer is: Which of the following tissues from polydactyly digit, iliac apophysis or other bio-banked cartilage produce better cartilage in vitro and in vivo? Participants receiving digit amputation surgery for treatment of polydactyly will be asked to donate the associated waste tissue whilst participants receiving surgery to treat a dislocated hip will be asked to donate an extra small piece of cartilage tissue (approximately 1 gram) from the iliac apophysis. Other tissues for the study will be obtained from those donated to biobanks.
Status | Recruiting |
Enrollment | 325 |
Est. completion date | September 1, 2037 |
Est. primary completion date | June 30, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: For juvenile/infant donors: - Parents/guardians being able to provide signed and dated informed consent form. - Scheduled for one of the following surgical treatments: Digit amputations due to polydactyly. Surgery to treat dislocated hips. For biobank/NHSBT donors - Informed consent via consenting institution. Exclusion Criteria: - Parents/guardians not understanding the Patient Information Sheet |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust | Oswestry | Shropshrie |
Lead Sponsor | Collaborator |
---|---|
Keele University | Alder Hey Children's NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, NHS Blood and Transplant, Norfolk and Norwich University Hospitals NHS Foundation Trust, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Royal National Orthopaedic Hospital NHS Trust, Scottish National Blood Transfusion Service, The Royal Orthopaedic Hospital NHS Trust, University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cell viability as assessed by trypan blue exclusion assay | The viability of cells post-collagenase digest will be assessed by trypan blue exclusion assay | Up to 48 hours | |
Secondary | Measure levels of glycosaminoglycan content by 1,9-dimethylmethylene blue (DMMB) assay | Glycosaminoglycan levels will be measured post-chondrogenic induction by DMMB assay | Up to 3 months |
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