NCT05016011

Efficacy of Allogeneic UCMSCs for Treating Large Defects Knee Injury

Phase IIb Study Assessing the Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells for Knee Cartilage Injury

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Cytopeutics Sdn. Bhd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2021-08-23
• Last updated: 2024-01-03

Locations

1 site across 1 country: Malaysia