Osteoarthritis of the KneePhase 1/2NCT02003131
Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
A Phase 1/2 study testing Trophic factors from umbilical cord mesenchymal stem cells in people with Osteoarthritis of the Knee, run by Translational Biosciences at 1 site in Panama.
Trial summary
Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Trophic factors from umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePanama
- Study dates
- Dec 2013to Jun 2019
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and ability to understand the planned treatment.
- Subjects 18 years of age or older with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
Who cannot join
- Pregnant women or cognitively impaired adults.
- Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- Inflammatory or post infectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
- Intra-articular corticosteroid injection within the previous 3 months.
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- A major neurologic deficit.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
Trial locations and contacts
1 site in 1 country.
About this study
Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4 radiographic OA severity.
Read the detailed description
The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to two arms osteoarthritis patients with grade 2, 3, or 4 radiographic OA severity (20 per arm). The first arm will receive an intra-articular injection of MTF into the knee joint under fluoroscopy. The second arm will receive 12 subcutaneous MTF injections, once per week.
For both arms, the primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint function improvement as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Trophic factors from umbilical cord mesenchymal stem cells
- Keywords
- osteoarthritis, umbilical cord, mesenchymal, stem cells, trophic factors
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trophic factors from umbilical cord mesenchymal stem cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular knee injection of MTF | Other | Trophic factors from umbilical cord mesenchymal stem cells administered intra-articularly. Receives: Biological: Trophic factors from umbilical cord mesenchymal stem cells |
| Subcutaneous injection of MTF | Other | Trophic factors from umbilical cord mesenchymal stem cells administered subcutaneously once per week for 12 weeks. Receives: Biological: Trophic factors from umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 12 months
Secondary outcomes (2)
Number of participants with a change in joint function from baseline WOMAC assessment at 12 months
Measured: 12 months
Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system at 12 months
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 posted6 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Paz-Rodriguez, MD, Principal investigator, Translational Biosciences / Stem Cell Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003131
- Sponsor's protocol ID
- TBS-MTFOA-001
- Status last verified
- Aug 2017
- First submitted
- 2 Dec 2013
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT02003131
- Acronym / sponsor ID
- TBS-MTFOA-001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, umbilical cord, mesenchymal, stem cells, trophic factors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Translational BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 6 Dec 2013 (estimated)
- 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.
Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4 radiographic OA severity.
Detailed description
The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to two arms osteoarthritis patients with grade 2, 3, or 4 radiographic OA severity (20 per arm). The first arm will receive an intra-articular injection of MTF into the knee joint under fluoroscopy. The second arm will receive 12 subcutaneous MTF injections, once per week.
For both arms, the primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint function improvement as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular knee injection of MTF | Other | Biological: Trophic factors from umbilical cord mesenchymal stem cellsTrophic factors from umbilical cord mesenchymal stem cells administered intra-articularly. |
| Subcutaneous injection of MTF | Other | Biological: Trophic factors from umbilical cord mesenchymal stem cellsTrophic factors from umbilical cord mesenchymal stem cells administered subcutaneously once per week for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years and ability to understand the planned treatment.
- Subjects 18 years of age or older with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
Key exclusion criteria (12 listed)
- Pregnant women or cognitively impaired adults.
- Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- Inflammatory or post infectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
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 |
|---|---|---|
| Trophic factors from umbilical cord mesenchymal stem cells | Biological | Intra-articular knee injection of MTF, Subcutaneous injection of MTF |
Primary outcome
Number of participants with adverse events
Time frame: 12 months
2 secondary outcomes
Number of participants with a change in joint function from baseline WOMAC assessment at 12 months
Time frame: 12 months
Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system at 12 months
Time frame: 12 months
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 10 Aug 2017.
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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.
Jorge Paz-Rodriguez, MD principal investigator
Translational Biosciences / Stem Cell Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trophic factors from umbilical cord mesenchymal stem cells in people with Osteoarthritis of the Knee, run by Translational Biosciences at 1 site in Panama.
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 12 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 10 Aug 2017. 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 Panama. 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 combined 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.
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?
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?
Number of participants with 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?
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 10 Aug 2017.