NOVOCART 3D Treatment Following Microfracture Failure | NCT03219307

Studies
NOVOCART 3D Treatment Following Microfracture Failure

NCT03219307

Sponsor

Aesculap Biologics, LLC

Status

Active, not recruiting

Last Update Posted

Mar 21, 2025Actual

Enrollment

30Estimated

Phase

Phase 3

Conditions

Articular Cartilage Defect

Interventions

NOVOCART 3D

Countries

United States
Canada

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Jul 13, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 17, 2017Actual

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

Mar 19, 2025

Last Update Posted Date

Mar 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Detailed Description

This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NOVOCART 3D	Experimental	Matrix associated autologous chondrocyte implant	Combination Product: NOVOCART 3D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NOVOCART 3D	Combination Product	Matrix associated autologous chondrocyte implant	NOVOCART 3D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
KOOS pain subdomain score	Comparison of pain scores from the KOOS questionnaire from baseline	24 months

Secondary Outcomes

Measure	Description	Time Frame
KOOS function subdomain score	Comparison of function scores from the KOOS questionnaire from baseline	24 months
VAS pain scale	Comparison of pain from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participated in study AAG-G-H-1220
identified as a microfracture failure patient
voluntary consent to participate in the study

Exclusion Criteria:

other cartilage repair procedures performed on target knee
other conditions that would interfere with healing or evaluating outcomes
lesions requiring implants larger than 9cm2
non-compliance with requirements in study AAG-G-H-1220

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Spiro, PhD	Octane Biotherapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States
Ohio State University Wexner Medical Center

Label	URL
Main Clinical Study AAG-G-H-1220	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided