search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Allogenic adipose derived mesenchymal stem cells (AD-MSC)
Saline
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring allogenic adipose derived mesenchymal stem cells, adipose derived mesenchymal stem cells, mesenchymal stem cells, stem cells

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

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

    Single intraarticular knee injection with saline alone 10 mL saline

    Outcomes

    Primary Outcome Measures

    Observation (change) of adverse events
    Pain Diary first 30 days after treatment, any reported adverse events after treatment
    Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline
    (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))

    Secondary Outcome Measures

    Change in pain from baseline
    Numeric Rating Scale (NRS)
    Observation (change) of cartilage regeneration compared to baseline
    MRI Osteoarthritis Knee Score
    Observation (change) of quantitative cartilage regeneration compared to baseline
    Quantitative MRI (unit: stress and strain and volumen cartilage)
    Improvement (change) during clinical examination with range of motion compared to baseline
    Range of motion (unit: degrees)
    Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline
    Effusion tests (swelling) (unit: effusion (YES/NO))
    Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline
    Measure knee diameter (unit: cm)
    Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline
    Measure quadriceps muscle (unit: cm)
    Change in HLA-typing from baseline
    Bloodsample HLA-typing

    Full Information

    First Posted
    June 5, 2023
    Last Updated
    June 26, 2023
    Sponsor
    Aarhus University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05933434
    Brief Title
    Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
    Acronym
    STEMJOINT
    Official Title
    Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2030 (Anticipated)
    Study Completion Date
    October 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aarhus University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    allogenic adipose derived mesenchymal stem cells, adipose derived mesenchymal stem cells, mesenchymal stem cells, stem cells

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Interventional group Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group Single intraarticular knee injection with saline
    Masking
    ParticipantInvestigator
    Masking Description
    Double-blinded (participant and investigator)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC) 20 million AD-MSC in 10 mL saline
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Single intraarticular knee injection with saline alone 10 mL saline
    Intervention Type
    Biological
    Intervention Name(s)
    Allogenic adipose derived mesenchymal stem cells (AD-MSC)
    Intervention Description
    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 Type
    Other
    Intervention Name(s)
    Saline
    Intervention Description
    10 mL saline will be intraarticular injected using ultrasonic guidance.
    Primary Outcome Measure Information:
    Title
    Observation (change) of adverse events
    Description
    Pain Diary first 30 days after treatment, any reported adverse events after treatment
    Time Frame
    Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
    Title
    Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline
    Description
    (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))
    Time Frame
    Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
    Secondary Outcome Measure Information:
    Title
    Change in pain from baseline
    Description
    Numeric Rating Scale (NRS)
    Time Frame
    Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
    Title
    Observation (change) of cartilage regeneration compared to baseline
    Description
    MRI Osteoarthritis Knee Score
    Time Frame
    Baseline, 3 months, 12 months, 24 months
    Title
    Observation (change) of quantitative cartilage regeneration compared to baseline
    Description
    Quantitative MRI (unit: stress and strain and volumen cartilage)
    Time Frame
    Baseline, 3 months, 12 months, 24 months
    Title
    Improvement (change) during clinical examination with range of motion compared to baseline
    Description
    Range of motion (unit: degrees)
    Time Frame
    Baseline, 3 months, 12 months, 24 months
    Title
    Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline
    Description
    Effusion tests (swelling) (unit: effusion (YES/NO))
    Time Frame
    Baseline, 3 months, 12 months, 24 months
    Title
    Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline
    Description
    Measure knee diameter (unit: cm)
    Time Frame
    Baseline, 3 months, 12 months, 24 months
    Title
    Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline
    Description
    Measure quadriceps muscle (unit: cm)
    Time Frame
    Baseline, 3 months, 12 months, 24 months
    Title
    Change in HLA-typing from baseline
    Description
    Bloodsample HLA-typing
    Time Frame
    Baseline, 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rasmus Aabling, MD
    Phone
    +4528496767
    Email
    rasaab@clin.au.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Pedersen, Professor
    Email
    michael@clin.au.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rasmus Aabling, MD
    Organizational Affiliation
    University of Aarhus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

    We'll reach out to this number within 24 hrs