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Completed

NCT Number: NCT02034188

Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stem Cell Institute

Panama City, Panama

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cells

Biological

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Translational Biosciences

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2014
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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