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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Umbilical cord mesenchymal stem cells
Sponsored by
Translational Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, umbilical cord, mesenchymal, stem cells

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stem Cell Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Umbilical cord mesenchymal stem cells

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)
Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale
Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)
Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test
Number of participants with a change in mobility and leg function as measured by the 25 foot walking test
Number of participants with a change in quality of life as measured by the Short form 36 (SF-36) quality of life questionnaire
Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG)
Number of participants with a change in brain or spinal cord lesions as measured by gadolinium-enhanced magnetic resonance imaging (MRI)

Full Information

First Posted
January 9, 2014
Last Updated
August 8, 2017
Sponsor
Translational Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT02034188
Brief Title
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Official Title
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Biosciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, umbilical cord, mesenchymal, stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical cord mesenchymal stem cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Umbilical cord mesenchymal stem cells
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)
Time Frame
12 months
Title
Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale
Time Frame
12 months
Title
Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)
Time Frame
12 months
Title
Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test
Time Frame
12 months
Title
Number of participants with a change in mobility and leg function as measured by the 25 foot walking test
Time Frame
12 months
Title
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
Title
Number of participants experiencing pulmonary edema as measured by 12-lead electrocardiogram (ECG)
Time Frame
1 month, 3 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Paz-Rodriguez, MD
Organizational Affiliation
Translational Biosciences / Stem Cell Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stem Cell Institute
City
Panama City
Country
Panama

12. IPD Sharing Statement

Citations:
PubMed Identifier
29523171
Citation
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. Erratum In: J Transl Med. 2021 May 10;19(1):197.
Results Reference
derived

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

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