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

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ClinicalTrials.gov Identifier: NCT05933434
Recruitment Status : Not yet recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
Rasmus Roost Aabling, Aarhus University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2030
Estimated Study Completion Date : October 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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)

  8. Change in HLA-typing from baseline [ Time Frame: Baseline, 3 months ]
    Bloodsample HLA-typing


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933434


Contacts
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Contact: Rasmus Aabling, MD +4528496767 rasaab@clin.au.dk
Contact: Michael Pedersen, Professor michael@clin.au.dk

Sponsors and Collaborators
Aarhus University Hospital
Investigators
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Principal Investigator: Rasmus Aabling, MD University of Aarhus
More Information
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Responsible Party: Rasmus Roost Aabling, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT05933434    
Other Study ID Numbers: STEMJOINT01
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: June 2023

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