Clinical trial NCT02270905: Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
Official title: An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Knee Injuries
Keywords: meniscus
meniscectomy
decellularised
xenograft
Lead sponsor: Tissue Regenix Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain relief as assessed by Visual Analog Scale (VAS)
timeFrame: 24 months
Secondary outcomes:
measure: Knee functional improvement as assessed by patient questionnaires
timeFrame: 24 months
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: "Ortotrauma" Spółka Z Ograniczoną
city: Oswestry
country: United Kingdom
facility: The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST
state: Shropshire
city: Uxbridge
country: United Kingdom
facility: The Hillingdon Hospitals NHS FOUNDATION TRUST
city: York
country: United Kingdom
facility: Clifton Park Hospital
Study officials:
affiliation: The Hillingdon Hospitals NHS Foundation Trust
name: David Houlihan-Burne
role: PRINCIPAL_INVESTIGATOR
References: