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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)

• Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.

• Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity

• Medial, lateral or dual compartment OA as determined above

• BMI \<35

• Danish speaker

• Patients must be legally competent and must be able to sign the written consent

Locations
Other Locations
Denmark
Aarhus University
RECRUITING
Aarhus N
Contact Information
Primary
Rasmus Aabling, MD
rasaab@clin.au.dk
+4528496767
Backup
Michael Pedersen, Professor
michael@clin.au.dk
Time Frame
Start Date: 2024-03-07
Estimated Completion Date: 2030-10
Participants
Target number of participants: 80
Treatments
Active_comparator: Intervention
Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC)~20 million AD-MSC in 10 mL saline
Placebo_comparator: Control
Single intraarticular knee injection with saline alone~10 mL saline
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov