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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02034188
• Date of registration: 09/01/2014
• Prospective Registration: No
• Primary sponsor: Translational Biosciences
• Public title: Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
• Scientific title: Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis
• Date of first enrolment: January 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02034188
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Panama

Contacts

• Name: Jorge Paz-Rodriguez, MD
• Affiliation: Translational Biosciences / Stem Cell Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: Umbilical cord mesenchymal stem cells

Primary Outcome(s)

Number of participants with adverse events [Time Frame: 12 months]

Secondary Outcome(s)

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 with a change in disability as measured by Expanded Disability Status Scale (EDSS) [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 mobility and leg function as measured by the 25 foot walking test [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 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]

Number of participants with a change in upper extremity function as measured by the Nine Hole Peg Test [Time Frame: 12 months]

Secondary ID(s)

TBS-UCMSC-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors