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NCT Number: NCT05933434

Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Saline

Other

10 mL saline will be intraarticular injected using ultrasonic guidance.

Primary outcomes

  1. Observation (change) of adverse events

    Time frame: 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

    Time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years

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

Secondary outcomes

  1. Change in pain from baseline

    Time frame: 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

    Time frame: Baseline, 3 months, 12 months, 24 months

    MRI Osteoarthritis Knee Score

  3. Observation (change) of quantitative cartilage regeneration compared to baseline

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, 3 months, 12 months, 24 months

    Measure quadriceps muscle (unit: cm)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Pedersen, Professor

CONTACT

[email protected]

Rasmus Aabling, MD

CONTACT

[email protected]

+4528496767

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Acronym: STEMJOINT

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 6, 2023
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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