Phase III Controlled Trial of gMSC1 in Patients with Symptomatic Articular Cartilage Defects or Osteochondritis Dissecans in the Knee

A Randomized, Open-Label, Controlled, Phase III Trial Comparing guaranteed Mesenchymal Stem Cell 1 (gMSC1) versus Microfracture (MFx) in Patients with Symptomatic Articular Cartilage Defects or Osteochondritis Dissecans in the Knee

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080223548

Enrollment

Registered

2017-05-31

Start date

2017-10-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

articular cartilage defects / osteochondritis dissecans in the knee

Interventions

investigational material(s) Generic name etc : guaranteed Mesenchymal Stem Cell 1 (gMSC1) INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Articular cartilage defects / osteochondritis dissecans (OCD) in the knee 2) Index defects are International Cartilage Repair Society (ICRS) Articular cartilage injury classification Grade 3 or 4 cartilage defects or index defects are Nelson Grade 3 or 4 OCD lesions

Exclusion criteria

Exclusion criteria: 1) Articular cartilage defects / osteochondritis dissecans (OCD) in the both knees 2) Osteoarthritis (narrowing of medial joint space>=1/3 compared to normal) 3) Ligament injury needs surgical treatment, or less than 4 weeks between surgical treatment for ligament injury and gMSC1 transplantation or MFx 4) Meniscus injury needs surgical treatment, or less than 6 weeks between surgical treatment for meniscus injury and gMSC1 transplantation or MFx. Regardless of the timing of surgical treatment for meniscus injury, meniscal resection of 50% and over 5) Less than 1 year between surgical treatment except debridement for the lesions and gMSC1 transplantation or MFx

Design outcomes

Primary

Measure	Time frame
safety efficacy 1) Histological evaluation of cartilage repair at 52 weeks after gMSC1 transplantation or MFx 2) Knee Injury and Osteoarthritis Outcome Score at 52 weeks after gMSC1 transplantation or MFx Asssement and observation	—

Secondary

Measure	Time frame
safety efficacy 1) Anatomical evaluation of subchondral bone at 52 weeks after gMSC1 transplantation or MFx 2) EuroQol 5 Dimension 3) Time to Treatment Failure, etc. Asssement and observation	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026