Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

Knee Osteoarthritis Clinical Trial

— STEMJOINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933434
• Other study ID #: STEMJOINT01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 7, 2024
• Est. completion date: October 2030

Study information

• Verified date: June 2024
• Source: Aarhus University Hospital
• Contact: Rasmus Aabling, MD
• Phone: +4528496767
• Email: rasaab[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2030
• Est. primary completion date: October 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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
• BMI <35
• 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
• Knee instability on physical examination
• History of allergy to antibiotics
• Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
• Presence of other types of inflammatory arthritis

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation (change) of adverse events	Pain Diary first 30 days after treatment, any reported adverse events after treatment	Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Primary	Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline	(questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))	Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary	Change in pain from baseline	Numeric Rating Scale (NRS)	Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary	Observation (change) of cartilage regeneration compared to baseline	MRI Osteoarthritis Knee Score	Baseline, 3 months, 12 months, 24 months
Secondary	Observation (change) of quantitative cartilage regeneration compared to baseline	Quantitative MRI (unit: stress and strain and volumen cartilage)	Baseline, 3 months, 12 months, 24 months
Secondary	Improvement (change) during clinical examination with range of motion compared to baseline	Range of motion (unit: degrees)	Baseline, 3 months, 12 months, 24 months
Secondary	Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline	Effusion tests (swelling) (unit: effusion (YES/NO))	Baseline, 3 months, 12 months, 24 months
Secondary	Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline	Measure knee diameter (unit: cm)	Baseline, 3 months, 12 months, 24 months
Secondary	Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline	Measure quadriceps muscle (unit: cm)	Baseline, 3 months, 12 months, 24 months