Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

NCT05933434 | Recruiting Phase 1 DMC

• 1 other identifier: STEMJOINT01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

allogenic adipose derived mesenchymal stem cells; adipose derived mesenchymal stem cells; mesenchymal stem cells; stem cells

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Change in pain from baseline

  Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years

• 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

• Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline

  Baseline, 3 months, 12 months, 24 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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)

Control

PLACEBO COMPARATOR

Single intraarticular knee injection with saline alone 10 mL saline

Other: Saline

Interventions

Allogenic adipose derived mesenchymal stem cells (AD-MSC) BIOLOGICAL

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.

Intervention

Saline OTHER

10 mL saline will be intraarticular injected using ultrasonic guidance.

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Rasmus Aabling, MD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasmus Aabling, MD

CONTACT

+4528496767; rasaab@clin.au.dk

Michael Pedersen, Professor

CONTACT

michael@clin.au.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded (participant and investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Interventional group * Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group * Single intraarticular knee injection with saline

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 6, 2023
• Study Start: March 7, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)