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

NCT ID: NCT02034188

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Umbilical cord mesenchymal stem cells

Group Type: EXPERIMENTAL

Umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Interventions

Umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Translational Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Paz-Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Biosciences / Stem Cell Institute

Locations

Stem Cell Institute

Panama City, , Panama

Countries

Panama

References

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.

Reference Type: DERIVED

PMID: 29523171 (View on PubMed)

Other Identifiers

TBS-UCMSC-001

Identifier Type: -

Identifier Source: org_study_id