Developing Allogeneic Musculoskeletal Therapies
ConditionOsteoarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKeele University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parents/guardians being able to provide signed and dated informed consent form.
Informed consent via consenting institution.
Disqualifiers
Parents/guardians not understanding the Patient Information Sheet
Trial population
Juvenile/infant donors: Participants between 0-4 years of age scheduled for polydactyly digit amputation or hip dislocation surgeries at the RJAH Orthopaedic, Alder Hey, Norwich and Norfolk, Royal National Orthopaedic and Birmingham Women's and Children's Hospitals (where appropriate i.e. polydactyly only at Alder Hey, and Norwich and Norfolk. Biobank/NHSBT donors: Participants of any age that have consented to donating their cartilage tissues to a bio-bank.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cell viability as assessed by trypan blue exclusion assay
The viability of cells post-collagenase digest will be assessed by trypan blue exclusion assay
Time frame
Up to 48 hoursSecondary outcomes
1
Measure levels of glycosaminoglycan content by 1,9-dimethylmethylene blue (DMMB) assay
Glycosaminoglycan levels will be measured post-chondrogenic induction by DMMB assay
Time frame
Up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Keele University
Lead sponsor
Alder Hey Children's NHS Foundation Trust
Collaborator
Birmingham Women's and Children's NHS Foundation Trust
Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborator
Royal National Orthopaedic Hospital NHS Trust
Collaborator
Scottish National Blood Transfusion Service
Collaborator
NHS Blood and Transplant
Collaborator
University of Birmingham
Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Collaborator
The Royal Orthopaedic Hospital NHS Trust
Collaborator
Source ClinicalTrials.gov