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

Aarhus University Hospital1 site in 1 country80 target enrollmentMarch 7, 2024

ConditionsKnee Osteoarthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Aarhus University Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: Observation (change) of adverse events
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 7, 2024

End Date

October 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aarhus University Hospital

Responsible Party

Principal Investigator

Rasmus Roost Aabling

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
•Intraarticular tumor, infection or fracture
•Pregnancy and breast feeding
•Cognitive impairment
•Treatment with cytostatic drugs
•Previous intraarticular knee injection in the past 3 mo.
•Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(\>BMI 35)
•Previous ligament reconstruction
•Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
•Diabetes mellitus type 1 and 2

Outcomes

Primary Outcomes

Observation (change) of adverse events

Time Frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years

Pain Diary first 30 days after treatment, any reported adverse events after treatment

Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline

Time Frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years

(questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))

Secondary Outcomes

Observation (change) of cartilage regeneration compared to baseline(Baseline, 3 months, 12 months, 24 months)
Observation (change) of quantitative cartilage regeneration compared to baseline(Baseline, 3 months, 12 months, 24 months)
Improvement (change) during clinical examination with range of motion compared to baseline(Baseline, 3 months, 12 months, 24 months)
Change in pain from baseline(Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years)
Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline(Baseline, 3 months, 12 months, 24 months)
Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline(Baseline, 3 months, 12 months, 24 months)
Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline(Baseline, 3 months, 12 months, 24 months)