Knee OsteoarthritisPhase 1NCT03602872
Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis
A Phase 1 study testing Human allogeneic mesenchymal bone marrow derived stem cells in people with Knee Osteoarthritis, run by Clinica Santa Clarita, Mexico at 1 site in Mexico.
Trial summary
The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Human allogeneic mesenchymal bone marrow derived stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2019to Apr 2020
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers between 35-65 years.
- X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
- Chronic joint pain (>5 visual analogue scale) in knee.
- BMI ≤ 29.
- Voluntary acceptance and signature of informed consent.
- Willing to attend study visits and lab sample recollection.
- Lab values within normal reference values.
- Willing to use effective birth control methods.
Who cannot join
- Inflammatory arthritis.
- Generalized infection.
- Active cancer or history of cancer in the past 5 years.
- Receiving oral or intraarticular steroids.
- Positive labs for HIV, Hepatitis B or C.
- Recent trauma in the target joint.
Show all 15Show fewer
- Debris in joint.
- Subjects that have undergone or need to undergo arthroscopic knee surgery in the target joint.
- History of joint substitution, intraarticular fractures, osteotomy, arthroplasty or menisectomy.
- Clinically significant knee misalignment.
- Other illnesses that the investigator considers clinically significant.
- Participating in another clinical trial three months before enrolling.
- Women that are pregnant, lactating or result positive in the pregnancy test during screening.
- Known allergies to bovine products.
- Subjects taking anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.
The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
- Conditions
- Knee Osteoarthritis
- Being tested
- Human allogeneic mesenchymal bone marrow derived stem cells
- Keywords
- Knee osteoarthritis, safety, MSCs
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human allogeneic mesenchymal bone marrow derived stem cellsBiological
Intraarticular administration of 20x10^6 MSCs
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. Receives: Biological: Human allogeneic mesenchymal bone marrow derived stem cells |
| Group 2 | Experimental | Subjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. Receives: Biological: Human allogeneic mesenchymal bone marrow derived stem cells |
| Group 3 | Experimental | Subjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. Receives: Biological: Human allogeneic mesenchymal bone marrow derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation of all AE/SAEs
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
Measured: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Secondary outcomes (3)
Procedure tolerance (procedure pain/discomfort incidence)
The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.
Measured: 7 days after subject receives dosing
WOMAC questionnaire
The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Measured: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
OAKHQOL questionnaire
The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Measured: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study startAug 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Sponsor to start with different protocol, postponed due to COVID
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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Santa Clarita, Mexico
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José F Izquierdo, M.D., Principal investigator, External
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602872
- Sponsor's protocol ID
- PRO-OAR-BW-001
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT03602872
- Acronym / sponsor ID
- PRO-OAR-BW-001
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, safety, MSCs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor to start with different protocol, postponed due to COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinica Santa Clarita, MexicoIndustry (pharma, biotech, devices)
- Study start
- Aug 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 27 Jul 2018 (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 aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Human allogeneic mesenchymal bone marrow derived stem cellsSubjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. |
| Group 2 | Experimental | Biological: Human allogeneic mesenchymal bone marrow derived stem cellsSubjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. |
| Group 3 | Experimental | Biological: Human allogeneic mesenchymal bone marrow derived stem cellsSubjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female volunteers between 35-65 years.
- X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
- Chronic joint pain (>5 visual analogue scale) in knee.
- BMI ≤ 29.
- Voluntary acceptance and signature of informed consent.
Key exclusion criteria (15 listed)
- Inflammatory arthritis.
- Generalized infection.
- Active cancer or history of cancer in the past 5 years.
- Receiving oral or intraarticular steroids.
- Positive labs for HIV, Hepatitis B or C.
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 |
|---|---|---|
| Human allogeneic mesenchymal bone marrow derived stem cellsIntraarticular administration of 20x10^6 MSCs | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Safety evaluation of all AE/SAEs
Time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
3 secondary outcomes
Procedure tolerance (procedure pain/discomfort incidence)
Time frame: 7 days after subject receives dosing
WOMAC questionnaire
Time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
OAKHQOL questionnaire
Time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- 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. This study is not recruiting at the moment.
José F Izquierdo, M.D. principal investigator
External
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 Human allogeneic mesenchymal bone marrow derived stem cells in people with Knee Osteoarthritis, run by Clinica Santa Clarita, Mexico at 1 site in Mexico.
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 Jul 2020. 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 Mexico. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of all AE/SAEs (time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject). 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 15 Jul 2020.