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Developing Allogeneic Musculoskeletal Therapies

Sponsor: Keele University

NCT ID: NCT06167928

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 227 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
Not specified
Who
All
Number of participants
325
Started
2018-10-08
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for osteoarthritis
  • • Clinical study - 325 participants
  • • 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

Who can take part?

  • • Adults
  • • Diagnosed with osteoarthritis

Where?

  • • Oswestry - Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

Cartilage and bone injury and osteoarthritis (OA) continues to take its toll on the quality of life of a large proportion of the world's population. Clinicians and scientists at the Robert Jones \& Agnes Hunt Orthopaedic Hospital (RJAH) are part of the Versus Arthritis Tissue Engineering Centre. The investigators have a long history of developing innovative cell-based therapies for the treatment of cartilage and bone defects and osteoarthritis, such as, autologous chondrocyte implantation, which is considered a successful treatment for chondral defects. However, there are potential drawbacks to the use of this procedure to treat larger osteochondral defects that arise in OA. These include the potential shortage of cartilage tissue available in OA patients and the fact that those cells obtained may have phenotypes preventing the reproduction of good quality cartilage. It is therefore favourable to seek a source of cells optimal for osteochondrogenesis for every patient. To further our studies the investigators wish to collect amputated digits that are removed in the routine treatment of polydactyly. The investigators also intend to study cells isolated from the iliac apophysis, these tissues will be removed during surgeries in the treatment of dislocated hips. In addition, the investigators intend to receive joint tissues from collaborative orthopaedic hospital tissue biobanks and National Health Service Blood and Transplant (NHS-BT). Our intention is to study the potential of cells derived from these tissues in the treatment of other patients with cartilage or bone injuries or osteoarthritis. In the first instance, the investigators propose to evaluate the use of various sources of cells for musculoskeletal therapies including bone, bone marrow and cartilage, although skin, fat and other tissues might also be attractive sources. Stem cells derived from these tissues are known to be capable of differentiating into cells which might be suitable for musculoskeletal repair strategies, i.e. osteoblasts and chondrocytes, to form bone and cartilaginous tissues. Thus these cells are attractive candidates for allogenic cell therapies for treatment of OA tissue damage. Furthermore the expected high vitality of the juvenile cells may allow for several patients to be treated by one characterised source. This will help to lower the cost of providing a cell therapy.

Osteoarthritis

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Not specified
  • Who can join: All genders

What the study is looking for

  • ✓For juvenile/infant donors:
  • ✓Parents/guardians being able to provide signed and dated agreement to take part form.
  • ✓Scheduled for one of the following surgical treatments:
  • ✓Digit amputations due to polydactyly. Surgery to treat dislocated hips.
  • ✓For biobank/NHSBT donors

Who cannot take part

  • ✗Parents/guardians not understanding the Patient Information Sheet
See the full criteria
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

Where Is This Study? (1 UK site)

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Oswestry SY10 7AG, United Kingdom

Recruiting
Site contact (verified)
Karina T WrightPrincipal Investigator

How to Get in Touch

Karina T Wright, PhD

Sponsor contact

CONTACT

+441691404022 karina.wright1@nhs.net

Sharon J Owen, PhD

Sponsor contact

CONTACT

+441691404295 sharon.owen12@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-06