OsteoarthritisNCT06167928
Developing Allogeneic Musculoskeletal Therapies
An observational study of Osteoarthritis, run by Keele University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- How many people
- 325 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2018to 1 Sep 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Parents/guardians not understanding the Patient Information Sheet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Oswestry, Shropshrie, SY10 7AG
Karina T Wright, PhD, +441691404022, karina.wright1@nhs.net
Karina T Wright
About this study
Official 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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Keywords
- Cell therapy, Musculoskeletal, Allogeneic
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell viability as assessed by trypan blue exclusion assay
The viability of cells post-collagenase digest will be assessed by trypan blue exclusion assay
Measured: Up to 48 hours
Secondary 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
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start8 Oct 2018
- Primary completion30 Jun 2028 (estimated)
- Study completion1 Sep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Royal National Orthopaedic Hospital NHS Trust, Scottish National Blood Transfusion Service, NHS Blood and Transplant, University of Birmingham, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, The Royal Orthopaedic Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Karina T Wright, PhD, Principal investigator, ISTM, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167928
- Sponsor's protocol ID
- RG-0245-17-ISTM
- Other IDs
- 21157, MR/5015167/1, 225835, 17/NW/0550
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06167928
- Acronym / sponsor ID
- RG-0245-17-ISTM
- Conditions
- Osteoarthritis
- Keywords
- Cell therapy, Musculoskeletal, Allogeneic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust, Royal National Orthopaedic Hospital NHS Trust, Scottish National Blood Transfusion Service, NHS Blood and Transplant, University of Birmingham, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, The Royal Orthopaedic Hospital NHS Trust
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 1 Sep 2037 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Parents/guardians not understanding the Patient Information Sheet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Measure levels of glycosaminoglycan content by 1,9-dimethylmethylene blue (DMMB) assay
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karina T Wright, PhD principal investigator
ISTM, Keele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Keele University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karina T Wright, PhD (+441691404022, karina.wright1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell viability as assessed by trypan blue exclusion assay (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.