Osteoarthritis, KneePhase 1ExoOA-1NCT05060107
Intra-articular Injection of MSC-derived Exosomes in Knee Osteoarthritis (ExoOA-1)
A Phase 1 study testing Exosomes (sEVs) in people with Osteoarthritis, Knee, run by Francisco Espinoza.
Trial summary
The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Exosomes (sEVs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2021to 5 Oct 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic knee OA with VAS >50mm
- Knee OA Kellgren-Lawrence grade II to III
- Chondromalacia grade I to III
- Stable joint
Who cannot join
- Bilateral symptomatic knee OA
- Local infection
- Neoplasia
- Joint replacement
- Recent use of local steroids
- BMI > 30
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)
The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Exosomes (sEVs)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosomes (sEVs)Biological
Exosomes 3-5x10e11 particles/dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental group - sEVs | Experimental | Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose. Receives: Biological: Exosomes (sEVs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Ocurrence of any adverse reactions within 12 months of treatment
Measured: 12 months
Secondary outcomes (5)
Incidence of injection-related pain according to VAS scale (0-100mm)
Pain measured by VAS scale after first week of treatment
Measured: 1 week
Incidence of injection-related sinovitis according to effusion grading scale of knee joint
Synovitis measured by effusion grading scale (zero to 3+) after first week of treatment
Measured: 1 week
Pain reduction
Change in VAS score after 52 weeks
Measured: 52 weeks
Disability reduction
Change in Womac subscale related to function (C) after 52 weeks
Measured: 52 weeks
Percentage of responders
According to OMERACT-OARSI Criteria Index Response after 52 weeks
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start5 Oct 2021 (estimated)
- Primary completion5 Apr 2023 (estimated)
- Study completion5 Oct 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Espinoza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Espinoza, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060107
- Sponsor's protocol ID
- C4C060921
- Acronym
- ExoOA-1
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Aiming to Assess Safety and Efficacy of a Single Intra-articular Injection of MSC-derived Exosomes (CelliStem®OA-sEV) in Patients With Moderate Knee Osteoarthritis (ExoOA-1)
- ClinicalTrials.gov ID
- NCT05060107
- Acronym / sponsor ID
- ExoOA-1 / C4C060921
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Francisco EspinozaUniversity, hospital or other
- Study start
- 5 Oct 2021 (estimated)
- Primary completion
- 5 Apr 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 28 Sep 2021 (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.
The study aim to evaluate safety of exosomes (sEVs) from allogeneic mesenchymal stromal cells delivered by an intra-articular injection in the knee of patients with mild to moderate symptomatic osteoarthritis. The sEVs will be produced in a GMP-facility. We expect to enrolle 10 patients in this phase 1 trial and the follow-up will be up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group - sEVs | Experimental | Biological: Exosomes (sEVs)Intra-articular knee injection of exosomes (3-5 x 10e11 particles) derived from allogeneic mesenchymal stromal cells. Single dose. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic knee OA with VAS >50mm
- Knee OA Kellgren-Lawrence grade II to III
- Chondromalacia grade I to III
- Stable joint
Key exclusion criteria (6 listed)
- Bilateral symptomatic knee OA
- Local infection
- Neoplasia
- Joint replacement
- Recent use of local steroids
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 |
|---|---|---|
| Exosomes (sEVs)Exosomes 3-5x10e11 particles/dose | Biological | Experimental group - sEVs |
Primary outcome
Adverse Event
Time frame: 12 months
Ocurrence of any adverse reactions within 12 months of treatment
5 secondary outcomes
Incidence of injection-related pain according to VAS scale (0-100mm)
Time frame: 1 week
Incidence of injection-related sinovitis according to effusion grading scale of knee joint
Time frame: 1 week
Pain reduction
Time frame: 52 weeks
Disability reduction
Time frame: 52 weeks
Percentage of responders
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis, Knee
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exosomes (sEVs) in people with Osteoarthritis, Knee, run by Francisco Espinoza.
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 4 inclusion and 6 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jose Matas, MD (+56 2 26183347 ext. 3347, jmatas@clinicauandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: 12 months). 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 28 Sep 2021.