Knee InjuriesNCT02270905
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
A study testing dCELL® Meniscus in people with Knee Injuries, run by Tissue Regenix Ltd at 4 sites in 2 countries.
Trial summary
The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- dCELL® Meniscus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy
- Must be a stable, well aligned knee with ligament laxity of Grade II or less
- Osteoarthritis <grade 3 on the Kellgren Lawrence scale
- Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol
Who cannot join
- Body Mass Index (BMI) greater than 35 kg/m2
- Treatment with any investigational drug or device within two months prior to screening
- Patients presenting with abnormal degenerative osteoarthritis of the joint
- Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months
- Patients using anticoagulants
- Patients on current immuno-suppressive or radiation therapy or having received such therapies within six months of screening
- Patients with diabetes or cardiovascular disease which precludes elective surgery
- Patients with documented renal disease or metabolic bone disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
Oswestry, Shropshire
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge
Clifton Park Hospital
York
About this study
Official title: An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.
Read the detailed description
The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.
- Conditions
- Knee Injuries
- Being tested
- dCELL® Meniscus
- Keywords
- meniscus, meniscectomy, decellularised, xenograft
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCELL® MeniscusDevice
decellularised porcine xenograft
| Study group | Role | What they receive |
|---|---|---|
| dCELL® Meniscus | Experimental | Not described Receives: Device: dCELL® Meniscus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief as assessed by Visual Analog Scale (VAS)
Change in VAS Pain score from baseline
Measured: 24 months
Secondary outcomes (1)
Knee functional improvement as assessed by patient questionnaires
IKDC, Lysholm and KOOS score change over time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tissue Regenix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Houlihan-Burne, Principal investigator, The Hillingdon Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270905
- Sponsor's protocol ID
- TRG-D02-01
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2014
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
- ClinicalTrials.gov ID
- NCT02270905
- Acronym / sponsor ID
- TRG-D02-01
- Conditions
- Knee Injuries
- Keywords
- meniscus, meniscectomy, decellularised, xenograft
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tissue Regenix LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- 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 safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.
Detailed description
The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dCELL® Meniscus | Experimental | Device: dCELL® Meniscus |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy
- Must be a stable, well aligned knee with ligament laxity of Grade II or less
- Osteoarthritis <grade 3 on the Kellgren Lawrence scale
- Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol
Key exclusion criteria (8 listed)
- Body Mass Index (BMI) greater than 35 kg/m2
- Treatment with any investigational drug or device within two months prior to screening
- Patients presenting with abnormal degenerative osteoarthritis of the joint
- Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months
- Patients using anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dCELL® Meniscusdecellularised porcine xenograft | Device | dCELL® Meniscus |
Primary outcome
Pain relief as assessed by Visual Analog Scale (VAS)
Time frame: 24 months
Change in VAS Pain score from baseline
1 secondary outcome
Knee functional improvement as assessed by patient questionnaires
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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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. This study is not recruiting at the moment.
David Houlihan-Burne principal investigator
The Hillingdon Hospitals NHS Foundation Trust
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCELL® Meniscus in people with Knee Injuries, run by Tissue Regenix Ltd at 4 sites in 2 countries.
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 4 inclusion and 8 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: paused, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief as assessed by Visual Analog Scale (VAS) (time frame: 24 months). 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 20 Nov 2018.