Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy (STEMJOINT)

Aarhus University Hospital

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC); Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05933434

STEMJOINT01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC) 20 million AD-MSC in 10 mL saline

Treatment:

Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC)

Control

Placebo Comparator group

Description:

Single intraarticular knee injection with saline alone 10 mL saline

Treatment:

Other: Saline