NOVOCART 3D Treatment Following Microfracture Failure

• Sponsor: Aesculap Biologics, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03219307
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 120
• Patients Per Site: 15
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Articular Cartilage Defect	Combination Product: NOVOCART 3D	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
• Actual Study Start Date: Nov 30, 2018
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NOVOCART 3D Matrix associated autologous chondrocyte implant	Combination Product: NOVOCART 3D; Matrix associated autologous chondrocyte implant

Outcome Measures

Primary Outcome Measures

1. KOOS pain subdomain score [24 months]

   Comparison of pain scores from the KOOS questionnaire from baseline

Secondary Outcome Measures

1. KOOS function subdomain score [24 months]

   Comparison of function scores from the KOOS questionnaire from baseline

2. VAS pain scale [24 months]

   Comparison of pain from baseline

3. IKDC subjective scores [24 months]

   Comparison of IKDC subjective scores from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 66 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University	Columbus	Ohio	United States	43202
2	Alpine Orthopaedics	North Logan	Utah	United States	84341

Sponsors and Collaborators

• Aesculap Biologics, LLC

Investigators

• Study Director: Robert Spiro, PhD, Aesculap Biologics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Main Clinical Study AAG-G-H-1220

Publications

None provided.

• Responsible Party: Aesculap Biologics, LLC
• ClinicalTrials.gov Identifier: NCT03219307
• Other Study ID Numbers: AAG-G-H-1703
• First Posted: Jul 17, 2017
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Aesculap Biologics, LLC: cartilage repair; cartilage regeneration; cartilage reconstruction; cartilage restoration; autologous chondrocyte implantation; matrix associated chondrocyte implantation
• Additional relevant MeSH terms: Cartilage Diseases; Fractures, Stress

Study Results

No Results Posted as of Mar 2, 2022