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Developing Allogeneic Musculoskeletal Therapies

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06167928
Enrollment
325
Registered
2023-12-13
Start date
2018-10-08
Completion date
2037-09-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Cell therapy, Musculoskeletal, Allogeneic

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.

Detailed description

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.

Interventions

None listed

Sponsors

Keele University
Lead SponsorOTHER
Alder Hey Children's NHS Foundation Trust
CollaboratorOTHER
Birmingham Women's and Children's NHS Foundation Trust
CollaboratorOTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
CollaboratorOTHER
Royal National Orthopaedic Hospital NHS Trust
CollaboratorOTHER
Scottish National Blood Transfusion Service
CollaboratorUNKNOWN
NHS Blood and Transplant
CollaboratorOTHER_GOV
University of Birmingham
CollaboratorOTHER
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
CollaboratorOTHER_GOV
The Royal Orthopaedic Hospital NHS Trust
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cell viability as assessed by trypan blue exclusion assayUp to 48 hoursThe viability of cells post-collagenase digest will be assessed by trypan blue exclusion assay

Secondary

MeasureTime frameDescription
Measure levels of glycosaminoglycan content by 1,9-dimethylmethylene blue (DMMB) assayUp to 3 monthsGlycosaminoglycan levels will be measured post-chondrogenic induction by DMMB assay

Countries

United Kingdom

Contacts

CONTACTKarina T Wright, PhD
karina.wright1@nhs.net+441691404022
CONTACTSharon J Owen, PhD
sharon.owen12@nhs.net+441691404295
PRINCIPAL_INVESTIGATORKarina T Wright, PhD

ISTM, Keele University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026