Developing Allogeneic Musculoskeletal Therapies

NCT06167928 | Recruiting

• 5 other identifiers: RG-0245-17-ISTM21157MR/5015167/122583517/NW/0550
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Cell therapy; Musculoskeletal; Allogeneic

Outcome Measures

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

  Up to 48 hours

Secondary Outcomes (1)

• Measure levels of glycosaminoglycan content by 1,9-dimethylmethylene blue (DMMB) assay

  Up to 3 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Parents/guardians not understanding the Patient Information Sheet

Sponsors & Collaborators

• Keele University: lead
• 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

Study Sites (1)

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Oswestry, Shropshrie, SY10 7AG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The bone and cartilage tissue samples will be anonymised and given a unique laboratory number. Any identifiable data (which links the patient to this laboratory number) will be accessible only by the named investigators as a hard copy in a locked storage facility and electronically on a password protected system which complies with the NHS IT security policy. Cells may be isolated from tissues and culture expanded in the laboratory. Cells and tissues will be appropriately stored either at -80 degrees Celsius or in liquid nitrogen.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Karina T Wright, PhD

  ISTM, Keele University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina T Wright, PhD

CONTACT

+441691404022; karina.wright1@nhs.net

Sharon J Owen, PhD

CONTACT

+441691404295; sharon.owen12@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 13, 2023
• Study Start: October 8, 2018
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 1, 2037
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)