Trials / Suspended
SuspendedNCT02270905
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Tissue Regenix Ltd · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | dCELL® Meniscus | decellularised porcine xenograft |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2014-10-21
- Last updated
- 2018-11-20
Locations
4 sites across 2 countries: Poland, United Kingdom
Source: ClinicalTrials.gov record NCT02270905. Inclusion in this directory is not an endorsement.