Phase 2 Clinical Trial of CartiLife® in the United States

Part of paid clinical trials in Irvine, California.

Sponsor
Biosolution Co., Ltd.
Study ID
NCT04744402
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Articular Cartilage Defect
  • Articular Cartilage Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous Chondrocyte Implantation (CartiLife®) — DRUG
    CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm\^3 defect

Study Details

To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration.

Key Dates

Start date
Oct 28, 2020
Status verified
Aug 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CartiLife®
    Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.

Primary Outcome Measure

Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities) [ Time Frame: Week 0 (pre-operation) to Week 48 (post-operation) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Tilda ResearchIrvineCalifornia92612
Kenneth Deck, MD (PRINCIPAL_INVESTIGATOR)
Biosolutions Clinical Research CenterLa MesaCalifornia91942
Tamara Packard
[email protected]
Peter Hanson, MD (PRINCIPAL_INVESTIGATOR)
Horizon Clinical ResearchLa MesaCalifornia91942
Dino Subasic
[email protected]
Scott Hacker, MD (PRINCIPAL_INVESTIGATOR)
Lafayette General HealthLafayetteLouisiana70506
Alaina Sandoz
[email protected]
Brian E Etier, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Angela Pedroza
[email protected]
David Flanigan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
Tilda Research· Irvine, CABiosolutions Clinical Research Center· La Mesa, CAHorizon Clinical Research· La Mesa, CALafayette General Health· Lafayette, LAOhio State University· Columbus, OH

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