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

November 19, 2018 updated by: Tissue Regenix Ltd

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland
        • "Ortotrauma" Spółka Z Ograniczoną
  • United Kingdom
      • Uxbridge, United Kingdom
        • The Hillingdon Hospitals NHS Foundation Trust
      • York, United Kingdom
        • Clifton Park Hospital
    • Shropshire
      • Oswestry, Shropshire, United Kingdom
        • The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dCELL® Meniscus
Device: dCELL® Meniscus
decellularised porcine xenograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief as assessed by Visual Analog Scale (VAS)
Time Frame: 24 months
Change in VAS Pain score from baseline
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee functional improvement as assessed by patient questionnaires
Time Frame: 24 months
IKDC, Lysholm and KOOS score change over time
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tissue Regenix Ltd

Investigators

  • Principal Investigator: David Houlihan-Burne, The Hillingdon Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRG-D02-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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