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Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02270905
Recruitment Status : Suspended
First Posted : October 21, 2014
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Tissue Regenix Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Injuries Device: dCELL® Meniscus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dCELL® Meniscus Device: dCELL® Meniscus
decellularised porcine xenograft




Primary Outcome Measures :
  1. Pain relief as assessed by Visual Analog Scale (VAS) [ Time Frame: 24 months ]
    Change in VAS Pain score from baseline


Secondary Outcome Measures :
  1. Knee functional improvement as assessed by patient questionnaires [ Time Frame: 24 months ]
    IKDC, Lysholm and KOOS score change over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270905


Locations
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Poland
"Ortotrauma" Spółka Z Ograniczoną
Bialystok, Poland
United Kingdom
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
Oswestry, Shropshire, United Kingdom
The Hillingdon Hospitals NHS FOUNDATION TRUST
Uxbridge, United Kingdom
Clifton Park Hospital
York, United Kingdom
Sponsors and Collaborators
Tissue Regenix Ltd
Investigators
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Principal Investigator: David Houlihan-Burne The Hillingdon Hospitals NHS Foundation Trust
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Responsible Party: Tissue Regenix Ltd
ClinicalTrials.gov Identifier: NCT02270905    
Other Study ID Numbers: TRG-D02-01
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Keywords provided by Tissue Regenix Ltd:
meniscus
meniscectomy
decellularised
xenograft
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries