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Phase 2B Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis

NCT04520945 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-08-20

No results posted yet for this study

Summary

Primary osteoarthritis is a debilitating disease characterized by extensive damage to the joints and excruciating pain leading to loss of activity and depression. Despite advances in diagnosis, the quest for the development of a disease-modifying osteoarthritis drug has proven unsuccessful. Human cartilage only has limited regenerative potential. Transplantation is a promising strategy given the high proliferative capacity of MSCs and their potential to differentiate into cartilage-producing cells - chondrocytes. The acquisition of MSC does not require invasive surgical intervention or cartilage extraction from other sites as required by other cell-based strategies. The investigators inject allogeneic human mesenchymal stem cells to the cartilage lesions in patients via intra-articular injection method, and to investigate the efficacy and safety.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Chondrogen

Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid

BIOLOGICAL

Placebo

Consist of saline and hyaluronic acid

Sponsors & Collaborators

  • Meluha Life Sciences SDN BHD

    lead INDUSTRY

Principal Investigators

  • Badrul Akmal Hisham, MBBS · PPUKM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-09-30
Completion
2022-09-30

Countries

  • Malaysia

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Entities

Drugs

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 NCT04520945 on ClinicalTrials.gov