NCT02034188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-sclerosis

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

January 9, 2014

Last Update Submit

August 8, 2017

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisumbilical cordmesenchymalstem cells

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    12 months

Secondary Outcomes (8)

  • Number of participants with a change in disability as measured by Expanded Disability Status Scale (EDSS)

    12 months

  • Number of participants with a change in neurological impairment as measured by Scripps Neurological Rating Scale

    12 months

  • Number of participants with a change in cognitive function as measured by the • Paced Auditory Serial Addition Test (PASAT)

    12 months

  • Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test

    12 months

  • Number of participants with a change in mobility and leg function as measured by the 25 foot walking test

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Umbilical cord mesenchymal stem cells

EXPERIMENTAL
Biological: Umbilical cord mesenchymal stem cells

Interventions

Umbilical cord mesenchymal stem cellsBIOLOGICAL
Umbilical cord mesenchymal stem cells

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell Institute

Panama City, Panama

Location

Related Publications (1)

  • 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.

    PMID: 29523171DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jorge Paz-Rodriguez, MD

    Translational Biosciences / Stem Cell Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

PA(1)