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NCT Number: NCT06167928

Developing Allogeneic Musculoskeletal Therapies

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Oswestry, Shropshrie, SY10 7AG, United Kingdom

Location status: Recruiting

Location contact

Karina T Wright

PRINCIPAL_INVESTIGATOR

Karina T Wright, PhD

CONTACT

[email protected]

+441691404022

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cell viability as assessed by trypan blue exclusion assay

    Time frame: Up to 48 hours

    The viability of cells post-collagenase digest will be assessed by trypan blue exclusion assay

Secondary outcomes

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

    Time frame: Up to 3 months

    Glycosaminoglycan levels will be measured post-chondrogenic induction by DMMB assay

Study contacts

Contact information is provided by the study sponsor or research team.

Karina T Wright, PhD

CONTACT

[email protected]

+441691404022

Sharon J Owen, PhD

CONTACT

[email protected]

+441691404295

Sponsors and collaborators

Lead sponsor

Keele University

Other

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2028
Study completion
2037
First posted
Dec 13, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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