NCT01957722: N3D

A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects

Active, enrolled Phase 3 Last updated 19 March 2025

What this trial tests

Phase 3 trial testing Microfracture in Articular Cartilage of the Femoral Condyle Between 2-6cm2 in 233 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2013

Primary endpoint
1 December 2025

1 December 2027

Quick facts

Lead sponsor	Aesculap Biologics, LLC
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	233
Start date	1 December 2013
Primary completion	1 December 2025
Estimated completion	1 December 2027
Sites	35 locations across United States, Canada

Drugs / interventions tested

• Microfracture
• NOVOCART 3D — full drug profile →

Conditions studied

• Articular Cartilage of the Femoral Condyle Between 2-6cm2 — all drugs for Articular Cartilage of the Femoral Condyle Between 2-6cm2 →

Sponsor

Aesculap Biologics, LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Articular Cartilage of the Femoral Condyle Between 2-6cm2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
  Time frame: 24 months post treatment
  As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
• Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
  Time frame: 24 months post treatment
  As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline

Sponsor's own description

This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell-based tissue engineering strategies used in the clinical repair of articular cartilage.
   Huang BJ, Hu JC, Athanasiou KA. · · 2016 · cited 274× · PMID 27177218 · DOI 10.1016/j.biomaterials.2016.04.018
2. Trends in clinical trials for articular cartilage repair by cell therapy.
   Negoro T, Takagaki Y, Okura H, Matsuyama A. · · 2018 · cited 71× · PMID 30345076 · DOI 10.1038/s41536-018-0055-2
3. Insights into the present and future of cartilage regeneration and joint repair.
   Evenbratt H, Andreasson L, Bicknell V, Brittberg M, et al · · 2022 · cited 29× · PMID 35106664 · DOI 10.1186/s13619-021-00104-5
4. Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.
   Kim J, Park J, Song SY, Kim E. · · 2022 · cited 14× · PMID 35582708 · DOI 10.1016/j.reth.2022.04.004
5. 3D-bioprinting for joint regeneration.
   Li W, Wang Y, Cui Y, Wu Q, et al · · 2026 · PMID 42027392 · DOI 10.3389/fbioe.2026.1742269