STEMJOINT: Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05933434
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 84

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC); Other: Saline	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Interventional group Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group Single intraarticular knee injection with salineInterventional group Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group Single intraarticular knee injection with saline
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blinded (participant and investigator)
• Primary Purpose: Treatment
• Official Title: Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2030
• Anticipated Study Completion Date: Oct 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC) 20 million AD-MSC in 10 mL saline	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.
Placebo Comparator: Control Single intraarticular knee injection with saline alone 10 mL saline	Other: Saline; 10 mL saline will be intraarticular injected using ultrasonic guidance.

Outcome Measures

Primary Outcome Measures

1. Observation (change) of adverse events [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

2. Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline [Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years]

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

Secondary Outcome Measures

1. Change in pain from baseline [Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years]

   Numeric Rating Scale (NRS)

2. Observation (change) of cartilage regeneration compared to baseline [Baseline, 3 months, 12 months, 24 months]

   MRI Osteoarthritis Knee Score

3. Observation (change) of quantitative cartilage regeneration compared to baseline [Baseline, 3 months, 12 months, 24 months]

   Quantitative MRI (unit: stress and strain and volumen cartilage)

4. Improvement (change) during clinical examination with range of motion compared to baseline [Baseline, 3 months, 12 months, 24 months]

   Range of motion (unit: degrees)

5. Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline [Baseline, 3 months, 12 months, 24 months]

   Effusion tests (swelling) (unit: effusion (YES/NO))

6. Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline [Baseline, 3 months, 12 months, 24 months]

   Measure knee diameter (unit: cm)

7. Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline [Baseline, 3 months, 12 months, 24 months]

   Measure quadriceps muscle (unit: cm)

8. Change in HLA-typing from baseline [Baseline, 3 months]

   Bloodsample HLA-typing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 and anterior-posterior laxity of 3mm or above 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

• Principal Investigator: Rasmus Aabling, MD, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rasmus Roost Aabling, MD, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT05933434
• Other Study ID Numbers: STEMJOINT01
• First Posted: Jul 6, 2023
• Last Update Posted: Jul 6, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rasmus Roost Aabling, MD, Aarhus University Hospital: allogenic adipose derived mesenchymal stem cells; adipose derived mesenchymal stem cells; mesenchymal stem cells; stem cells
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jul 6, 2023