Articular Cartilage DefectPhase 3NCT03219307
NOVOCART 3D Treatment Following Microfracture Failure
A Phase 3 study testing NOVOCART 3D in people with Articular Cartilage Defect, run by Aesculap Biologics, LLC at 5 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Articular Cartilage Defect
- What is being tested?
- NOVOCART 3D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Nov 2018to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participated in study AAG-G-H-1220
- identified as a microfracture failure patient
- voluntary consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
Ohio State University Wexner Medical Center
Columbus, Ohio, 43202
Alpine Orthopaedics
North Logan, Utah, 84341
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
Dalhousie University
Halifax, Nova Scotia, B3H 2E1
About this study
Official title: Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
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.
- Conditions
- Articular Cartilage Defect
- Being tested
- NOVOCART 3D
- Keywords
- cartilage repair, cartilage regeneration, cartilage reconstruction, cartilage restoration, autologous chondrocyte implantation, matrix associated chondrocyte implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVOCART 3DCombination product
Matrix associated autologous chondrocyte implant
| Study group | Role | What they receive |
|---|---|---|
| NOVOCART 3D | Experimental | Matrix associated autologous chondrocyte implant Receives: Combination Product: NOVOCART 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS pain subdomain score
Comparison of pain scores from the KOOS questionnaire from baseline
Measured: 24 months
Secondary outcomes (3)
KOOS function subdomain score
Comparison of function scores from the KOOS questionnaire from baseline
Measured: 24 months
VAS pain scale
Comparison of pain from baseline
Measured: 24 months
IKDC subjective scores
Comparison of IKDC subjective scores from baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start30 Nov 2018
- Primary completionJan 2026 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Spiro, PhD, Study director, Octane Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219307
- Sponsor's protocol ID
- AAG-G-H-1703
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2017
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture
- ClinicalTrials.gov ID
- NCT03219307
- Acronym / sponsor ID
- AAG-G-H-1703
- Conditions
- Articular Cartilage Defect
- Keywords
- cartilage repair, cartilage regeneration, cartilage reconstruction, cartilage restoration, autologous chondrocyte implantation, matrix associated chondrocyte implantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aesculap Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVOCART 3D | Experimental | Combination Product: NOVOCART 3DMatrix associated autologous chondrocyte implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participated in study AAG-G-H-1220
- identified as a microfracture failure patient
- voluntary consent to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVOCART 3DMatrix associated autologous chondrocyte implant | Combination product | NOVOCART 3D |
Primary outcome
KOOS pain subdomain score
Time frame: 24 months
Comparison of pain scores from the KOOS questionnaire from baseline
3 secondary outcomes
KOOS function subdomain score
Time frame: 24 months
VAS pain scale
Time frame: 24 months
IKDC subjective scores
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Main Clinical Study AAG-G-H-1220Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Spiro, PhD study director
Octane Biotherapeutics, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NOVOCART 3D in people with Articular Cartilage Defect, run by Aesculap Biologics, LLC at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS pain subdomain score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.