Clinical trial NCT02237547: Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
Official title: Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
mesenchymal
bone marrow
mononuclear cells
stem cells
umbilical cord
Lead sponsor: Translational Biosciences
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.

Detailed description: The proposed study will assess primary safety and secondary efficacy endpoints of autologous bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem cells administered to 20 male and female subjects between ages of 18-50 with spinal cord injury. These cells will be administered intrathecally and intravenously multiple times over the course of one month.

The primary objective is freedom from treatment-associated adverse events at 3 and 12 months post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and will be quantified based on the following: American Spinal Cord Injury Association (ASIA) classification and the Frankel Scale.

Eligibility 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 12 weeks, 52 weeks
Secondary outcomes:
measure: Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
timeFrame: 12 weeks, 52 weeks
measure: Number of subjects with a change in Frankel Scale score from baseline
timeFrame: 12 weeks, 52 weeks
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Stem Cell Institute
Study officials:
name: Nelson Novarro, MD
role: PRINCIPAL_INVESTIGATOR
References: