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Recruiting NCT05933434

Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

Phase I / Phase II Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allogenic adipose derived mesenchymal stem cells (AD-MSC), Saline.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Observation (change) of adverse events [Time frame: 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 [Time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years]
Secondary outcome measures (7)
  • Change in pain from baseline [Time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years]
  • Observation (change) of cartilage regeneration compared to baseline [Time frame: Baseline, 3 months, 12 months, 24 months]
  • Observation (change) of quantitative cartilage regeneration compared to baseline [Time frame: Baseline, 3 months, 12 months, 24 months]
  • Improvement (change) during clinical examination with range of motion compared to baseline [Time frame: Baseline, 3 months, 12 months, 24 months]
  • Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline [Time frame: Baseline, 3 months, 12 months, 24 months]
  • Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline [Time frame: Baseline, 3 months, 12 months, 24 months]
  • Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline [Time frame: Baseline, 3 months, 12 months, 24 months]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Aarhus University — Aarhus N

Identifiers

NCT: NCT05933434 · STEMJOINT01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗