Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02237547
• Date of registration: 09/09/2014
• Prospective Registration: No
• Primary sponsor: Translational Biosciences
• Public title: Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
• Scientific title: Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
• Date of first enrolment: September 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02237547
• 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: Nelson Novarro, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women between age 18 and 50

- Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.

- Willingness to undergo bone marrow derived autologous cell therapy.

- Ability and willingness to make regular visits to hospital and follow ups during the
protocol procedure and comply with all medical instructions

- Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance
Imaging (MRI) and injury level below C4

- ASIA impairment scale from A - C

- Must have proof of health insurance in country of residence.

- Signed informed consent

Exclusion Criteria:

- Pre- existing or current systemic disease such as lung, liver (exception: history of
uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus
(HIV)

- History of life threatening allergic- or immune-mediated reaction

- Hemodynamic instability

- Peripheral muscular dystrophy

- Lactating or pregnant woman

- Women capable of childbearing unwilling to use multiple forms of contraception

- Alcohol drug abuse /dependence

- Positive test result for hepatitis A and Hepatitis B OR C

- Major-traumatic brain injury and psychiatric illness

- Open injuries

- Active infectious diseases

- Life expectancy of less than one year due to terminal condition

- Neurodegenerative diseases

- Primary hematologic diseases

- Any of the following medications that cannot be discontinued one week prior to the
first stem cell administration and throughout the course of treatment. (1 week before
visit 2 through one week after visit 12)

- Antibiotics

- Antifungals

- Antivirals

- Blood thinners (to avoid bleeding risk during bone marrow aspiration and IT
procedures)

- High doses of Vitamin D or fish oils (since these might prolong bleeding times)

- Bone reflecting increased risk for spinal puncture

- Hepatic dysfunction

- Other medical complications that contraindicate surgery, including major respiratory
complications

- Participation in another clinical trial

- Coagulopathies

- Uncorrected coagulopathy during the baseline period defined as: International
Normalized Ratio (INR) > 1.4; Partial Thromboplastin Time (PTT) > 35 sec; Platelet
Count (PLT) < 100,000.

- Pre-injury history of seizure disorder and/or neurological impairment where
participation in age-appropriate pain rating scales would not be practical or possible

- Subject does not sign informed consent form



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Cord Injury

Intervention(s)

Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells

Primary Outcome(s)

Number of patients with adverse events [Time Frame: 12 weeks, 52 weeks]

Secondary Outcome(s)

Number of subjects with a change in Frankel Scale score from baseline [Time Frame: 12 weeks, 52 weeks]

Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline [Time Frame: 12 weeks, 52 weeks]

Secondary ID(s)

CNEI-2014-TBS-UCMSC-SCI001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors