Multiple SclerosisPhase 1/2NCT02034188
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
A Phase 1/2 study testing Umbilical cord mesenchymal stem cells in people with Multiple Sclerosis, run by Translational Biosciences at 1 site in Panama.
Trial summary
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Umbilical cord mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePanama
- Study dates
- Jan 2014to Mar 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients willing to sign informed consent and capable of understanding the features of this clinical trial.
- Willing to keep a weekly diary and undergo observation for 12 months
- Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Poser criteria for clinically defined MS.
- EDSS scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of MS.
- Must have proof of health insurance in country of residence.
Who cannot join
- Patients with evidence of active proliferative retinopathy.
- Patients with poorly controlled diabetes mellitus (glycated hemoglobin: HbA1C > 8.5%).
- Patients with renal insufficiency (Creatinine> 2.5) or failure.
- Infection as evidenced by white blood cell (WBC) count of >15,000 k/cumm and/or temperature > 38 Celsius.
- History of organ transplant.
- History of previous or active malignancy, except for localised cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix
Show all 12Show fewer
- Exercise limiting angina ( Canadian Cardiovascular Society Class 3
- Congestive heart failure (New York Heart Association class 3
- Unstable angina
- Acute ST elevation myocardial infarction (MI) within 1month
- Transient ischemic heart attack or stroke within 1 month
- Severe valvular heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.
Read the detailed description
The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 20 patients with MS.
The primary objective of the trial is freedom from treatment associated adverse events at 4,12 and 52 weeks post treatment. Secondary objective will be efficacy as assessed at baseline, week 12 and 52 and will be quantified based on the following: Neurological assessment of the MS functional composite assessment which comprises of Expanded Disability Status Scale (EDSS), the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time. Short-form 36 (SF-36) quality of life questionnaire and gadolinium enhanced MRI scans of the brain and cervical spinal cord will also be performed at the indicated time points.
- Conditions
- Multiple Sclerosis
- Being tested
- Umbilical cord mesenchymal stem cells
- Keywords
- multiple sclerosis, umbilical cord, mesenchymal, stem cells
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord mesenchymal stem cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord mesenchymal stem cells | Experimental | Not described Receives: Biological: 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 (8)
Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)
Measured: 12 months
Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale
Measured: 12 months
Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)
Measured: 12 months
Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test
Measured: 12 months
Number of participants with a change in mobility and leg function as measured by the 25 foot walking test
Measured: 12 months
Number of participants with a change in quality of life as measured by the Short form 36 (SF-36) quality of life questionnaire
Measured: 12 months
Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG)
Measured: 1 month, 3 months
Number of participants with a change in brain or spinal cord lesions as measured by gadolinium-enhanced magnetic resonance imaging (MRI)
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 posted13 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
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 Multiple SclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02034188
- Sponsor's protocol ID
- TBS-UCMSC-001
- Status last verified
- Aug 2017
- First submitted
- 9 Jan 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Riordan NH, Morales I, Fernandez G, Allen N, Fearnot NE, Leckrone ME, Markovich DJ, Mansfield D, Avila D, Patel AN, Kesari S, Paz Rodriguez J. Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis. J Transl Med. 2018 Mar 9;16(1):57. doi: 10.1186/s12967-018-1433-7.
PubMed 29523171
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
- Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02034188
- Acronym / sponsor ID
- TBS-UCMSC-001
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, umbilical cord, mesenchymal, stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Translational BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2014 (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 human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.
Detailed description
The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 20 patients with MS.
The primary objective of the trial is freedom from treatment associated adverse events at 4,12 and 52 weeks post treatment. Secondary objective will be efficacy as assessed at baseline, week 12 and 52 and will be quantified based on the following: Neurological assessment of the MS functional composite assessment which comprises of Expanded Disability Status Scale (EDSS), the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time. Short-form 36 (SF-36) quality of life questionnaire and gadolinium enhanced MRI scans of the brain and cervical spinal cord will also be performed at the indicated time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord mesenchymal stem cells | Experimental | Biological: Umbilical cord mesenchymal stem cells |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients willing to sign informed consent and capable of understanding the features of this clinical trial.
- Willing to keep a weekly diary and undergo observation for 12 months
- Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Poser criteria for clinically defined MS.
- EDSS scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of MS.
- Must have proof of health insurance in country of residence.
Key exclusion criteria (12 listed)
- Patients with evidence of active proliferative retinopathy.
- Patients with poorly controlled diabetes mellitus (glycated hemoglobin: HbA1C > 8.5%).
- Patients with renal insufficiency (Creatinine> 2.5) or failure.
- Infection as evidenced by white blood cell (WBC) count of >15,000 k/cumm and/or temperature > 38 Celsius.
- History of organ transplant.
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 mesenchymal stem cells | Biological | Umbilical cord mesenchymal stem cells |
Primary outcome
Number of participants with adverse events
Time frame: 12 months
8 secondary outcomes
Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)
Time frame: 12 months
Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale
Time frame: 12 months
Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)
Time frame: 12 months
Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test
Time frame: 12 months
Number of participants with a change in mobility and leg function as measured by the 25 foot walking test
Time frame: 12 months
Number of participants with a change in quality of life as measured by the Short form 36 (SF-36) quality of life questionnaire
Time frame: 12 months
Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG)
Time frame: 1 month, 3 months
Number of participants with a change in brain or spinal cord lesions as measured by gadolinium-enhanced magnetic resonance imaging (MRI)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Derived from this study: PubMed 29523171Riordan NH, Morales I, Fernandez G, Allen N, Fearnot NE, Leckrone ME, Markovich DJ, Mansfield D, Avila D, Patel AN, Kesari S, Paz Rodriguez J. Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis. J Transl Med. 2018 Mar 9;16(1):57. doi: 10.1186/s12967-018-1433-7.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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 Umbilical cord mesenchymal stem cells in people with Multiple Sclerosis, 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 5 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT02034188, 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 10 Aug 2017.