NCT05933434

Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Allogenic adipose derived mesenchymal stem cells (AD-MSC)	Laboratory isolated, cultivated and cryopreserved allogenic adipose derived mesenchymal stem cells (AD-MSC) from health donors undergoing cometic plastic surgery will be thawed on the injection day and formulated in 10 mL saline. The AD-MSCs will then be intraarticular injected using ultrasonic guidance.
OTHER	Saline	10 mL saline will be intraarticular injected using ultrasonic guidance.

Timeline

• Start date: 2024-03-07
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2023-07-06
• Last updated: 2024-06-11

Locations

1 site across 1 country: Denmark