NCT00729716

Phase II Study to Investigate the Efficacy and Safety of BioCart™II in the Treatment of Symptomatic Cartilage Defects of the Femoral Condyle in Comparison With Microfracture

Status unknown Phase 2 Last updated 16 April 2012

What this trial tests

Phase 2 trial testing BioCart™II in Symptomatic Cartilage Defects of the Femoral Condyle in 40 participants. Status unknown.

Timeline

1 May 2008

Primary endpoint
1 May 2012

1 May 2015

Quick facts

Lead sponsor	ProChon Biotech Ltd
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 May 2008
Primary completion	1 May 2012
Estimated completion	1 May 2015
Sites	8 locations across United States, Israel

Drugs / interventions tested

• BioCart™II — full drug profile →
• Microfracture

Conditions studied

• Symptomatic Cartilage Defects of the Femoral Condyle — all drugs for Symptomatic Cartilage Defects of the Femoral Condyle →

Sponsor

ProChon Biotech Ltd — full company profile →

Who can join

Adults 16 to 60, any sex, with Symptomatic Cartilage Defects of the Femoral Condyle. 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.

• Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group
  Time frame: 12 months with optional follow up to 5 years

Sponsor's own description

BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment compared to microfracture which is the classical method of treatment.

Publications & conference data

4 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. How Can Nanotechnology Help to Repair the Body? Advances in Cardiac, Skin, Bone, Cartilage and Nerve Tissue Regeneration.
   Perán M, García MA, Lopez-Ruiz E, Jiménez G, et al · · 2013 · cited 18× · PMID 28809213 · DOI 10.3390/ma6041333
3. 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
4. The osteochondral regeneration paradox: why biomimetic scaffolds are biologically superior but injectable systems dominate the clinic.
   Gubert S, Moon H, Oliva N, Texidó R. · · 2026 · PMID 41767232 · DOI 10.1039/d5ra09529h