Osteoarthritis, KneePhase 1NCT05789719
An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis
A Phase 1 study testing STEM-OA in people with Osteoarthritis, Knee, run by StemMedical A/S at 1 site in Denmark.
Trial summary
A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- STEM-OA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 1 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
- Joint pain ≥ 30mm on 100mm VAS at screening
- Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion >1 cm in any dimension by x-ray
- Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
- Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive)
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- Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator.
- Agree to donate cells to alloSTEM-OA participants.
- Fulfils eligibility criteria for allogeneic cell- and tissue donors.
- Speaks and reads Danish or English
Who cannot join
- Active tobacco use, or use of other nicotine substitutes
- Active cancer or still in follow-up (5 years)
- Rheumatologic disease
- Avascular disease
- Severe bone deformity
- Previous infection of the knee joint
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- Pes anserine bursitis
- pain attributed to diffuse edema
- pain attributed to displaced meniscal tear or osteochondritis
- Neurogenic or vascular claudication
- Bleeding disorders
- Chemotherapy
- Radiation therapy to the leg or adipose harvested site
- Knee injections within 3 months of treatment
- Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication)
- Use of oral glucocorticoids.
- Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method.
- Known chronic disease associated with metabolism malfunction or poor healing.
- Allergy towards necessary anaesthesia
- Varus/valgus malalignment >5°
- Isolated patellofemoral arthrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.
A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Being tested
- STEM-OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEM-OABiological
Combination of autologous or allogeneic MSC(AT)s and fat
| Study group | Role | What they receive |
|---|---|---|
| autoSTEM-OA 400 | Experimental | 400x10^6 autologous MSC(AT)s in autologous fat Receives: Biological: STEM-OA |
| alloSTEM-OA 400 | Experimental | 400x10^6 allogeneic MSC(AT)s in autologous fat Receives: Biological: STEM-OA |
| autoSTEM-OA 800 | Experimental | 800x10^6 autologous MSC(AT)s in autologous fat Receives: Biological: STEM-OA |
| alloSTEM-OA 800 | Experimental | 800x10^6 allogeneic MSC(AT)s in autologous fat Receives: Biological: STEM-OA |
| autoSTEM-OA 1600 | Experimental | 1600x10^6 autologous MSC(AT)s in autologous fat Receives: Biological: STEM-OA |
| alloSTEM-OA 1600 | Experimental | 1600x10^6 allogeneic MSC(AT)s in autologous fat Receives: Biological: STEM-OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
STEM-OA safety
Number of treatment emergent adverse events (TEAEs)
Measured: 13 weeks
Secondary outcomes (2)
Knee pain
Change in KOOS 'pain' score
Measured: 13 weks
Number of treatment responders
Number of treatment responders according to the OMERACT-OARSI criteria
Measured: 13 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StemMedical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789719
- Sponsor's protocol ID
- ST-001
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05789719
- Acronym / sponsor ID
- ST-001
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- StemMedical A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 29 Mar 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.
A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| autoSTEM-OA 400 | Experimental | Biological: STEM-OA400x10^6 autologous MSC(AT)s in autologous fat |
| alloSTEM-OA 400 | Experimental | Biological: STEM-OA400x10^6 allogeneic MSC(AT)s in autologous fat |
| autoSTEM-OA 800 | Experimental | Biological: STEM-OA800x10^6 autologous MSC(AT)s in autologous fat |
| alloSTEM-OA 800 | Experimental | Biological: STEM-OA800x10^6 allogeneic MSC(AT)s in autologous fat |
| autoSTEM-OA 1600 | Experimental | Biological: STEM-OA1600x10^6 autologous MSC(AT)s in autologous fat |
| alloSTEM-OA 1600 | Experimental | Biological: STEM-OA1600x10^6 allogeneic MSC(AT)s in autologous fat |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
- Joint pain ≥ 30mm on 100mm VAS at screening
- Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion >1 cm in any dimension by x-ray
- Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
Key exclusion criteria (21 listed)
- Active tobacco use, or use of other nicotine substitutes
- Active cancer or still in follow-up (5 years)
- Rheumatologic disease
- Avascular disease
- Severe bone deformity
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 |
|---|---|---|
| STEM-OACombination of autologous or allogeneic MSC(AT)s and fat | Biological | alloSTEM-OA 1600, alloSTEM-OA 400, alloSTEM-OA 800, autoSTEM-OA 1600, autoSTEM-OA 400, autoSTEM-OA 800 |
Primary outcome
STEM-OA safety
Time frame: 13 weeks
Number of treatment emergent adverse events (TEAEs)
2 secondary outcomes
Knee pain
Time frame: 13 weks
Number of treatment responders
Time frame: 13 weks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STEM-OA in people with Osteoarthritis, Knee, run by StemMedical A/S 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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper Due Jensen, PhD (+45 51222087, jj@stemmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STEM-OA safety (time frame: 13 weeks). 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 29 Mar 2023.