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Efficacy of Allogeneic UCMSCs for Treating Large Defects Knee Injury

NCT05016011 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-01-03

No results posted yet for this study

Summary

In terms of the surgical treatment of the cartilage injury, various techniques and ways are created to repair or regenerate articular surface of synovial joint following traumatic damage or degeneration of the cartilage. The option for surgical treatments based on the size and depth of the cartilage knee injury may include knee debridement, radiofrequency, drilling, microfracture, mosaicplasty, allogenic osteochondral transplantation and autologous chondrocyte transplantation. The first two techniques mentioned have been used in treating the cartilage knee injury involving the partial defects meanwhile the latter techniques have been used for Grade III and IV cartilage defects based on ICRS. However, most of the surgical options up only provide more of Type I collagen rather than Type II collagen. The available treatments are more symptomatic rather than preventive or regenerative. Stem cell has big potential in this area where it has ability to differentiate to cartilage. As allogeneic umbilical cord blood MSCs are readily available and can be administered immediately, this study therefore aims to prove the efficacy of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) for treating large defects knee injury.

The study is a prospective, randomized controlled, open label, phase IIb clinical trial, involving 50 patients with large defects of cartilage injury for follow-up duration of 24 months. Patients will be assigned into 2 arms; Arm A - 25 subjects will receive Chondrocell-EX (UC-MSCs) and Arm B - 25 subject will receive marrow cellution. All patients will undergo debridement prior to receiving their assigned treatment. The patients will be assessed on KOOS, IKDC, VAS and MRI.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)

Human umbilical cord-derived mesenchymal stem cells

PROCEDURE

Marrow cellution

Patients will undergo marrow cellution surgical procedure.

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    collaborator OTHER

  • Cytopeutics Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

  • Badrul Akmal Hisham Md Yusoff · Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM-UKM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • Malaysia

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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 NCT05016011 on ClinicalTrials.gov