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Trial record 1 of 1 for:    NCT02034188
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Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02034188
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Umbilical cord mesenchymal stem cells Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Umbilical cord mesenchymal stem cells Biological: Umbilical cord mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS) [ Time Frame: 12 months ]
  2. Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale [ Time Frame: 12 months ]
  3. Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 12 months ]
  4. Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test [ Time Frame: 12 months ]
  5. Number of participants with a change in mobility and leg function as measured by the 25 foot walking test [ Time Frame: 12 months ]
  6. 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 ]
  7. Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG) [ Time Frame: 1 month, 3 months ]
  8. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034188


Locations
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Panama
Stem Cell Institute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
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Principal Investigator: Jorge Paz-Rodriguez, MD Translational Biosciences / Stem Cell Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT02034188    
Other Study ID Numbers: TBS-UCMSC-001
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Keywords provided by Translational Biosciences:
multiple sclerosis
umbilical cord
mesenchymal
stem cells
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases