Knee OsteoarthritisPhase 1/2STEMJOINTNCT05933434
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
A Phase 1/2 study testing Allogenic adipose derived mesenchymal stem cells (AD-MSC) and Saline in people with Knee Osteoarthritis, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Allogenic adipose derived mesenchymal stem cells (AD-MSC) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Mar 2024to Oct 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Pedersen, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University
Aarhus N, 8200
Rasmus Aabling, MD, +45 78450000, rasaab@clin.au.dk
About this study
Official title: Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
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
- Being tested
- Allogenic adipose derived mesenchymal stem cells (AD-MSC), Saline
- Keywords
- allogenic adipose derived mesenchymal stem cells, adipose derived mesenchymal stem cells, mesenchymal stem cells, stem cells
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
SalineOther
10 mL saline will be intraarticular injected using ultrasonic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC)
20 million AD-MSC in 10 mL saline Receives: Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC) |
| Control | Placebo comparator | Single intraarticular knee injection with saline alone
10 mL saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation (change) of adverse events
Pain Diary first 30 days after treatment, any reported adverse events after treatment
Measured: 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))
Measured: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary outcomes (7)
Change in pain from baseline
Numeric Rating Scale (NRS)
Measured: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Observation (change) of cartilage regeneration compared to baseline
MRI Osteoarthritis Knee Score
Measured: Baseline, 3 months, 12 months, 24 months
Observation (change) of quantitative cartilage regeneration compared to baseline
Quantitative MRI (unit: stress and strain and volumen cartilage)
Measured: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with range of motion compared to baseline
Range of motion (unit: degrees)
Measured: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline
Effusion tests (swelling) (unit: effusion (YES/NO))
Measured: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline
Measure knee diameter (unit: cm)
Measured: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline
Measure quadriceps muscle (unit: cm)
Measured: Baseline, 3 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start7 Mar 2024
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Roost Aabling, Aarhus University Hospital
- Investigators
- Rasmus Aabling, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933434
- Sponsor's protocol ID
- STEMJOINT01
- Acronym
- STEMJOINT
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
- ClinicalTrials.gov ID
- NCT05933434
- Acronym / sponsor ID
- STEMJOINT / STEMJOINT01
- Conditions
- Knee Osteoarthritis
- Keywords
- allogenic adipose derived mesenchymal stem cells, adipose derived mesenchymal stem cells, mesenchymal stem cells, stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Interventional group * Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group * Single intraarticular knee injection with saline
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC)Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC) 20 million AD-MSC in 10 mL saline |
| Control | Placebo comparator | Other: SalineSingle intraarticular knee injection with saline alone 10 mL saline |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- Intraarticular tumor, infection or fracture
- Pregnancy and breast feeding
- Cognitive impairment
- Treatment with cytostatic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Intervention |
| Saline10 mL saline will be intraarticular injected using ultrasonic guidance. | Other | Control |
Primary outcome
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
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))
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Pedersen, Professor contact
Rasmus Aabling, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogenic adipose derived mesenchymal stem cells (AD-MSC) and Saline in people with Knee Osteoarthritis, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasmus Aabling, MD (+4528496767, rasaab@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation (change) of adverse events (time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.