Clinical Evaluation of dCELL® Meniscus for Partial Replac... | NCT02270905

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

NCT02270905

Sponsor

Tissue Regenix Ltd

Status

Suspended

Last Update Posted

Nov 20, 2018Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Knee Injuries

Interventions

dCELL® Meniscus

Countries

Poland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 17, 2014

First Submission Date that Met QC Criteria

Oct 17, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2018

Last Update Posted Date

Nov 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dCELL® Meniscus	Experimental		Device: dCELL® Meniscus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dCELL® Meniscus	Device	decellularised porcine xenograft	dCELL® Meniscus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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 \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Houlihan-Burne	The Hillingdon Hospitals NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Ortotrauma" Spółka Z Ograniczoną		Bialystok			Poland
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST

Condition Browse Module

MeSH Terms

ID	Term
D007718	Knee Injuries

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided