NCT05016011

Efficacy of Allogeneic UCMSCs for Treating Large Defects Knee Injury

Completed Phase 2 Last updated 3 January 2024

What this trial tests

Phase 2 trial testing Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in Osteoarthritis, Knee in 28 participants. Completed in 21 March 2022.

Timeline

1 July 2020

Primary endpoint
21 March 2022

21 March 2022

Quick facts

Lead sponsor	Cytopeutics Sdn. Bhd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 July 2020
Primary completion	21 March 2022
Estimated completion	21 March 2022
Sites	1 location across Malaysia

Drugs / interventions tested

• Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) — full drug profile →
• Marrow cellution

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Cytopeutics Sdn. Bhd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Human Mesenchymal Stem/Stromal Cells in Immune Regulation and Therapy.
   Mezey É. · · 2022 · cited 28× · PMID 35298659 · DOI 10.1093/stcltm/szab020
2. Umbilical cord mesenchymal stromal cells-from bench to bedside.
   Chetty S, Yarani R, Swaminathan G, Primavera R, et al · · 2022 · cited 25× · PMID 36313578 · DOI 10.3389/fcell.2022.1006295
3. Cell-based therapy in the treatment of musculoskeletal diseases.
   Trapana J, Weinerman J, Lee D, Sedani A, et al · · 2024 · cited 18× · PMID 39226104 · DOI 10.1093/stcltm/szae049
4. Allogenic Perinatal Tissue for Musculoskeletal Regenerative Medicine Applications: A Systematic Review.
   Aratikatla A, Maffulli N, Rodriguez HC, Gupta M, et al · · 2022 · cited 14× · PMID 36551929 · DOI 10.3390/biomedicines10123173
5. Advanced Therapy medicinal products for autologous chondrocytes and comparison of regulatory systems in target countries.
   Kim J, Park J, Song SY, Kim E. · · 2022 · cited 14× · PMID 35582708 · DOI 10.1016/j.reth.2022.04.004
6. Fabricating the cartilage: recent achievements.
   Fani N, Peshkova M, Bikmulina P, Golroo R, et al · · 2023 · cited 3× · PMID 37389132 · DOI 10.1007/s10616-023-00582-2
7. Modular mastery of inflammation: umbilical cord mesenchymal stem cells as a therapeutic frontier.
   Yin L, Sun CY, Chen GL, Xiang Z, et al · · 2025 · PMID 41488628 · DOI 10.3389/fimmu.2025.1721947