Osteo Arthritis KneePhase 2PANLAR-IINCT05751564
"Ready-to-use" Intra-articular Formulation of Mesenchymal Stromal Cells
A Phase 2 study testing "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product and Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product in people with Osteo Arthritis Knee, run by Universidad de los Andes, Chile.
Trial summary
The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product and Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2025
- Phase
- Phase 2
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic knee OA defined by grade 1-3 Kellgren-Lawrence radiographic changes in the targeted knee.
- Daily pain at the affected joint for at least 3 months before inclusion
Who cannot join
- Bilateral symptomatic knee OA (only if the contralateral knee has more severe disease)
- Meniscal rupture.
- Condylar or tibial plateau generalized bone marrow edema on MRI
- Major axial deviation defined by valgus (>10°) or varus (5°) deformity of the involved leg
- Use of oral or intra-articular steroids or hyaluronic acid in the past 6 months
- Ipsilateral hip or ankle pain, local or systemic infection
- Any form of secondary arthritis, previous malignancy, or body mass index ≥30.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Enabling Advanced Medical Therapy in the Americas: A Pilot Study to Validate a "Ready-to-use" Intra-articular Formulation of Mesenchymal Stromal Cells, Aiming Toward an Effective and Scalable Treatment for Symptomatic Knee Osteoarthritis
The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients. Since usual MSC therapy requires cell manipulation in GMP (Good Manufacturing Practices)-type facilities, this new formulation would enable wider access to Cell therapy and Multicentric clinical trials in areas devoid of expensive facilities and equipment.
Read the detailed description
This is a double blind randomized controlled trial testing a modified formulation of an allogenic Umbilical cord (UC) derived MSC therapy that the investigators have used in a prior published clinical trial. It has been modified and characterized according to the standards of quality control that are required for the development an off-the-shelf cryopreserved MSCs product.
This so called "ready to inject" MSC preparation will be compared with the usual MSC formulation that requires centrifugation and resuspension in different media, thus requiring access to advanced (GMP-type) facilities.
A total of 60 symptomatic knee OA patients will be randomized (1.1 ratio) to receive one or the other MSC product at baseline and month 6, to be followed blindly for 12 months with baseline and end of study knee MRI imaging.
The primary endpoint of the trial will be the safety according to the occurrence of adverse events (AEs) as coded by the Common Terminology Criteria for Adverse Event classification. The secondary endpoint will be efficacy, as assessed by the following validated clinical outcome measures: Western Ontario and Mc Master Universities Arthritis Index (WOMAC) Spanish validated version, Pain Visual Analog scale (VAS), Quality of life by the Short-form 36 (SF-36) questionnaire, Patient Global Assessment, and the Outcome Measures in Rheumatology Committee (OMERACT)-Osteoarthritis Research Society International (OARSI) Responder Index Criteria. Baseline MRI will be performed mainly to exclude meniscal lesions associated with accelerated knee OA. Final (12 month) MRI will be performed to assess structural change in response to treatment
The completion of this project represents a main technological advance, eventually leading to the scalability and enhanced quality control of a much needed treatment, within reasonable costs and logistics, and in particular, with no need of a GMP facility at the point of care or of clinical testing
- Conditions
- Osteo Arthritis Knee
- Being tested
- "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product, Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product
- Keywords
- Osteoarthritis, Degenerative joint disease, Cell therapy, Advanced Medicinal Therapy Product, Mesenchymal Stromal Cell, Mesenchymal Stem Cell, Cryopreserved cell therapy
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) productBiological
Also called Cryopreserved "Ready to inject" MSC product
Cryopreserved thaw \& inject MSC intra-articular therapy
Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) productBiological
Also called Cryopreserved resuspended MSC product
Cryopreserved resuspended MSC intra-articular therapy
| Study group | Role | What they receive |
|---|---|---|
| "Ready to inject" MSC product | Experimental | Cryopreserved "ready to inject" Umbilical Cord (UC) derived MSC Receives: Biological: "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product |
| Resuspended MSC product | Active comparator | Umbilical Cord (UC) derived MSC in suspension media Receives: Biological: Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety monitoring for Adverse events
Adverse events (AEs) reported for each study group as coded by the Common Terminology Criteria for Adverse Event classification.
Measured: 12 months
Secondary outcomes (4)
WOMAC scale
Western Ontario and Mc Master Universities Arthritis Index (WOMAC) Spanish validated version. Scale ranges from 0-240 with higher scores indicating worsened state
Measured: 12 months
Pain Visual Analog Scale (VAS)
VAS scale for pain, ranging from 0-10 with higher scores indicating worsened state
Measured: 12 months
Quality of Life SF-36 questionnaire
Short-form 36 (SF-36) questionnaire, ranging from 0-100 with higher scores indicating better health status
Measured: 12 months
Responder status
Assessed by the Outcome Measures in Rheumatology Committee (OMERACT)-Osteoarthritis Research Society International (OARSI) Responder Index Criteria. Responder status requires fulfilling at least 50% improvement in pain or function with absolute change of at least 20; or at least 20% improvemente in pain, function or patient´s global assessment, with absolute change of at least 20.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (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 Osteo Arthritis 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Double blind Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
- Responsible party
- Sponsor
- Investigators
- Fernando E Figueroa, M.D., Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751564
- Sponsor's protocol ID
- PANLAR-II
- Acronym
- PANLAR-II
- Status last verified
- Jan 2023
- First submitted
- 9 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing upon request after publication of the trial.
Publications
Matas J, Orrego M, Amenabar D, Infante C, Tapia-Limonchi R, Cadiz MI, Alcayaga-Miranda F, Gonzalez PL, Muse E, Khoury M, Figueroa FE, Espinoza F. Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. Stem Cells Transl Med. 2019 Mar;8(3):215-224. doi: 10.1002/sctm.18-0053. Epub 2018 Dec 28.
PubMed 30592390
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Advanced Medical Therapy in the Americas: A Pilot Study to Validate a "Ready-to-use" Intra-articular Formulation of Mesenchymal Stromal Cells, Aiming Toward an Effective and Scalable Treatment for Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05751564
- Acronym / sponsor ID
- PANLAR-II / PANLAR-II
- Conditions
- Osteo Arthritis Knee
- Keywords
- Osteoarthritis, Degenerative joint disease, Cell therapy, Advanced Medicinal Therapy Product, Mesenchymal Stromal Cell, Mesenchymal Stem Cell, Cryopreserved cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 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.
The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients. Since usual MSC therapy requires cell manipulation in GMP (Good Manufacturing Practices)-type facilities, this new formulation would enable wider access to Cell therapy and Multicentric clinical trials in areas devoid of expensive facilities and equipment.
Detailed description
This is a double blind randomized controlled trial testing a modified formulation of an allogenic Umbilical cord (UC) derived MSC therapy that the investigators have used in a prior published clinical trial. It has been modified and characterized according to the standards of quality control that are required for the development an off-the-shelf cryopreserved MSCs product.
This so called "ready to inject" MSC preparation will be compared with the usual MSC formulation that requires centrifugation and resuspension in different media, thus requiring access to advanced (GMP-type) facilities.
A total of 60 symptomatic knee OA patients will be randomized (1.1 ratio) to receive one or the other MSC product at baseline and month 6, to be followed blindly for 12 months with baseline and end of study knee MRI imaging.
The primary endpoint of the trial will be the safety according to the occurrence of adverse events (AEs) as coded by the Common Terminology Criteria for Adverse Event classification. The secondary endpoint will be efficacy, as assessed by the following validated clinical outcome measures: Western Ontario and Mc Master Universities Arthritis Index (WOMAC) Spanish validated version, Pain Visual Analog scale (VAS), Quality of life by the Short-form 36 (SF-36) questionnaire, Patient Global Assessment, and the Outcome Measures in Rheumatology Committee (OMERACT)-Osteoarthritis Research Society International (OARSI) Responder Index Criteria. Baseline MRI will be performed mainly to exclude meniscal lesions associated with accelerated knee OA. Final (12 month) MRI will be performed to assess structural change in response to treatment
The completion of this project represents a main technological advance, eventually leading to the scalability and enhanced quality control of a much needed treatment, within reasonable costs and logistics, and in particular, with no need of a GMP facility at the point of care or of clinical testing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Double blind Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| "Ready to inject" MSC product | Experimental | Biological: "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) productCryopreserved "ready to inject" Umbilical Cord (UC) derived MSC |
| Resuspended MSC product | Active comparator | Biological: Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) productUmbilical Cord (UC) derived MSC in suspension media |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic knee OA defined by grade 1-3 Kellgren-Lawrence radiographic changes in the targeted knee.
- Daily pain at the affected joint for at least 3 months before inclusion
Key exclusion criteria (7 listed)
- Bilateral symptomatic knee OA (only if the contralateral knee has more severe disease)
- Meniscal rupture.
- Condylar or tibial plateau generalized bone marrow edema on MRI
- Major axial deviation defined by valgus (>10°) or varus (5°) deformity of the involved leg
- Use of oral or intra-articular steroids or hyaluronic acid in the past 6 months
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 |
|---|---|---|
| "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) productAlso: Cryopreserved "Ready to inject" MSC productCryopreserved thaw \& inject MSC intra-articular therapy | Biological | "Ready to inject" MSC product |
| Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) productAlso: Cryopreserved resuspended MSC productCryopreserved resuspended MSC intra-articular therapy | Biological | Resuspended MSC product |
Primary outcome
Safety monitoring for Adverse events
Time frame: 12 months
Adverse events (AEs) reported for each study group as coded by the Common Terminology Criteria for Adverse Event classification.
4 secondary outcomes
WOMAC scale
Time frame: 12 months
Pain Visual Analog Scale (VAS)
Time frame: 12 months
Quality of Life SF-36 questionnaire
Time frame: 12 months
Responder status
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 30592390Matas J, Orrego M, Amenabar D, Infante C, Tapia-Limonchi R, Cadiz MI, Alcayaga-Miranda F, Gonzalez PL, Muse E, Khoury M, Figueroa FE, Espinoza F. Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. Stem Cells Transl Med. 2019 Mar;8(3):215-224. doi: 10.1002/sctm.18-0053. Epub 2018 Dec 28.
- Individual participant dataSharing planned: Yes. Sharing upon request after publication of the trial.
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
Fernando E Figueroa, M.D. principal investigator
Universidad de los Andes, Chile
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Ready to inject" Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product and Resuspended Umbilical cord-derived Mesenchymal Stromal Cell (MSC) product in people with Osteo Arthritis Knee, run by Universidad de los Andes, 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 2 inclusion and 7 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 2 Mar 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando E Fernando, M.D. (+56 953722433, ffigueroa@uandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety monitoring for Adverse events (time frame: 12 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 NCT05751564, 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 2 Mar 2023.