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A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee

NCT06549686 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-11-24

No results posted yet for this study

Summary

To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee (OAK).

Conditions

  • Osteoarthritis of the Knee

Interventions

BIOLOGICAL

CLS2901C (human [allogeneic] chondrocyte sheets)

CLS2901C (human \[allogeneic\] chondrocyte sheets)

Sponsors & Collaborators

  • CellSeed Inc.

    lead INDUSTRY

Principal Investigators

  • Manabu Ishizuka · CellSeed Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2027-07-31
Completion
2031-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549686 on ClinicalTrials.gov