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

Knee Injuries Clinical Trial

Official title:

An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02270905
• Other study ID #: TRG-D02-01
• Status: Suspended
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: Tissue Regenix Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 32
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• dCELL® Meniscus
decellularised porcine xenograft

Locations

Country	Name	City	State
Poland	"Ortotrauma" Spólka Z Ograniczona	Bialystok
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

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Regenix Ltd

Countries where clinical trial is conducted

Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief as assessed by Visual Analog Scale (VAS)	Change in VAS Pain score from baseline	24 months
Secondary	Knee functional improvement as assessed by patient questionnaires	IKDC, Lysholm and KOOS score change over time	24 months