Osteoarthritis, KneePhase 1CLT-OA1NCT03810521
Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis
A Phase 1 study testing umbilical cord derived-mesenchymal stromal cells in people with Osteoarthritis, Knee, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- umbilical cord derived-mesenchymal stromal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2019to 30 Dec 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 30 and 75 years old
- Knee-OA Kellgren Lawrence grade I to III
- Pain density according to visual analogue scale superior or equal to 50 mm
- Patelar condromalacia grade I to III
- Stable joint with normal physical exploration
Who cannot join
- Bilateral symptomatic disease
- Local or systemic infection
- Neoplasia
- Immunosuppression state
- Pregnancy
- Anticoagulant therapy
Show all 10Show fewer
- Other types of arthritis
- Symptomatic disease of hip and/or spine
- Intra-articular infiltration with steroids in the last 3 months
- Intra-articular infiltration with hyaluronic acid in the last 12 months
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Clínica Universidad de los Andes
Santiago, XIII, 7620001
Jose Matas, MD, 56226181000, jmatas@uandes.cl
Eduardo Carrasco, MD, 56226181000, ecarrasco@clinicauandes.cl
About this study
Official title: A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Being tested
- umbilical cord derived-mesenchymal stromal cells
- Keywords
- mesenchymal stromal 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.
umbilical cord derived-mesenchymal stromal cellsBiological
Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
| Study group | Role | What they receive |
|---|---|---|
| CLT low-dose | Experimental | Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee Receives: Biological: umbilical cord derived-mesenchymal stromal cells |
| CLT medium-dose | Experimental | Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee Receives: Biological: umbilical cord derived-mesenchymal stromal cells |
| CLT high-dose | Experimental | Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee Receives: Biological: umbilical cord derived-mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 6 months
Secondary outcomes (3)
Change in WOMAC score
Measured: 6 months
Change in VAS score
Measured: 6 months
Changes in structural joint assessment by MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Espinoza, Universidad de los Andes, Chile
- Investigators
- Francisco Espinoza, MD, Principal investigator, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810521
- Sponsor's protocol ID
- CLT-OA1
- Acronym
- CLT-OA1
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matas J, Garcia C, Poblete D, Vernal R, Ortloff A, Luque-Campos N, Hidalgo Y, Cuenca J, Infante C, Cadiz MI, Khoury M, Luz-Crawford P, Espinoza F. A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis. Stem Cells Transl Med. 2024 Mar 15;13(3):193-203. doi: 10.1093/stcltm/szad088.
PubMed 38366909
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)
- ClinicalTrials.gov ID
- NCT03810521
- Acronym / sponsor ID
- CLT-OA1 / CLT-OA1
- Conditions
- Osteoarthritis, Knee
- Keywords
- mesenchymal stromal cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 Jan 2019 (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 I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CLT low-dose | Experimental | Biological: umbilical cord derived-mesenchymal stromal cellsUmbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee |
| CLT medium-dose | Experimental | Biological: umbilical cord derived-mesenchymal stromal cellsUmbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee |
| CLT high-dose | Experimental | Biological: umbilical cord derived-mesenchymal stromal cellsUmbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient between 30 and 75 years old
- Knee-OA Kellgren Lawrence grade I to III
- Pain density according to visual analogue scale superior or equal to 50 mm
- Patelar condromalacia grade I to III
- Stable joint with normal physical exploration
Key exclusion criteria (10 listed)
- Bilateral symptomatic disease
- Local or systemic infection
- Neoplasia
- Immunosuppression state
- Pregnancy
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 |
|---|---|---|
| umbilical cord derived-mesenchymal stromal cellsIntra-articular infiltration of umbilical cord derived-mesenchymal stromal cells | Biological | CLT high-dose, CLT low-dose, CLT medium-dose |
Primary outcome
Incidence of adverse events
Time frame: 6 months
3 secondary outcomes
Change in WOMAC score
Time frame: 6 months
Change in VAS score
Time frame: 6 months
Changes in structural joint assessment by MRI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Derived from this study: PubMed 38366909Matas J, Garcia C, Poblete D, Vernal R, Ortloff A, Luque-Campos N, Hidalgo Y, Cuenca J, Infante C, Cadiz MI, Khoury M, Luz-Crawford P, Espinoza F. A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis. Stem Cells Transl Med. 2024 Mar 15;13(3):193-203. doi: 10.1093/stcltm/szad088.
- Individual participant dataSharing planned: No
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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.
Francisco Espinoza, MD principal investigator
CMO
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 umbilical cord derived-mesenchymal stromal cells in people with Osteoarthritis, Knee, run by Universidad de los Andes, Chile at 1 site in Chile.
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 5 inclusion and 10 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 18 Jan 2019. 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 Chile. 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 Francisco Espinoza, MD (56226181008, fespinoza@uandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810521, which also lists 1 linked publication.
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 18 Jan 2019.