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

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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

Tracking Information
First Submitted Date  ICMJE October 17, 2014
First Posted Date  ICMJE October 21, 2014
Last Update Posted Date November 20, 2018
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Pain relief as assessed by Visual Analog Scale (VAS) [ Time Frame: 24 months ]
Change in VAS Pain score from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Pain relief [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Knee functional improvement as assessed by patient questionnaires [ Time Frame: 24 months ]
IKDC, Lysholm and KOOS score change over time
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2014)
Knee functional improvement [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
Official Title  ICMJE An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Injuries
Intervention  ICMJE Device: dCELL® Meniscus
decellularised porcine xenograft
Study Arms  ICMJE Experimental: dCELL® Meniscus
Intervention: Device: dCELL® Meniscus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: July 15, 2016)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2014)
60
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02270905
Other Study ID Numbers  ICMJE TRG-D02-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tissue Regenix Ltd
Study Sponsor  ICMJE Tissue Regenix Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Houlihan-Burne The Hillingdon Hospitals NHS Foundation Trust
PRS Account Tissue Regenix Ltd
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP