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Active, not recruitingNCT03219307Updated Mar 21, 2025

NOVOCART 3D Treatment Following Microfracture Failure

A Phase 3 interventional study of NOVOCART 3D in Articular Cartilage Defect, sponsored by Aesculap Biologics, LLC. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Aesculap Biologics, LLC · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Articular Cartilage Defect

Keywords

  • cartilage repair
  • cartilage regeneration
  • cartilage reconstruction
  • cartilage restoration
  • autologous chondrocyte implantation
  • matrix associated chondrocyte implantation
03

In context

Cartilage Diseases

73 studies on the registry are indexed under Cartilage Diseases; 5 are open to participants now.

This study's planned enrollment of 30 is below the median of 47 across 49 interventional studies indexed under Cartilage Diseases.

Browse Cartilage Diseases studies →

Lead sponsor

Aesculap Biologics, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    NOVOCART 3D

    Matrix associated autologous chondrocyte implant

    Combination Product: NOVOCART 3D

Interventions

  • Combination productNOVOCART 3D

    Matrix associated autologous chondrocyte implant

06

What researchers measure

Primary outcomes

  1. KOOS pain subdomain score

    Comparison of pain scores from the KOOS questionnaire from baseline

    Time frame: 24 months

Secondary outcomes

  1. KOOS function subdomain score

    Comparison of function scores from the KOOS questionnaire from baseline

    Time frame: 24 months

  2. VAS pain scale

    Comparison of pain from baseline

    Time frame: 24 months

  3. IKDC subjective scores

    Comparison of IKDC subjective scores from baseline

    Time frame: 24 months

07

Study locations

5 sites
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43202, United States
  • Alpine Orthopaedics
    North Logan, Utah 84341, United States
  • University of Alberta
    Edmonton, Alberta T6G 2B7, Canada
  • Dalhousie University
    Halifax, Nova Scotia B3H 2E1, Canada
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03219307
Lead sponsor
Aesculap Biologics, LLC
Responsible party
Sponsor
First posted
Jul 17, 2017
Start date
Nov 30, 2018
Primary completion
Jan 2026 (estimated)
Completion
Jan 2029 (estimated)
Last update
Mar 21, 2025

Study contacts

Robert Spiro, PhD
study director · Octane Biotherapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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