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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences
ClinicalTrials.gov Identifier:
NCT02034188
First received: January 9, 2014
Last updated: August 26, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Multiple Sclerosis
Biological: Umbilical cord mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1//2 Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Translational Biosciences:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: January 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Umbilical cord mesenchymal stem cells Biological: Umbilical cord mesenchymal stem cells

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034188

Locations
Panama
Stem Cell Institute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
Principal Investigator: Jorge Paz-Rodriguez, MD Translational Biosciences / Stem Cell Institute
  More Information

Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT02034188     History of Changes
Other Study ID Numbers: TBS-UCMSC-001
Study First Received: January 9, 2014
Last Updated: August 26, 2016

Keywords provided by Translational Biosciences:
multiple sclerosis
umbilical cord
mesenchymal
stem cells

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on March 23, 2017