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

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ClinicalTrials.gov Identifier: NCT02237547
Recruitment Status : Withdrawn (No enrollment.)
First Posted : September 11, 2014
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
Study Start Date : September 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV and IT UC-MSC and BMMC
Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 12 weeks, 52 weeks ]
    12 and 52 weeks after final treatment


Secondary Outcome Measures :
  1. Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline [ Time Frame: 12 weeks, 52 weeks ]
    12 and 52 weeks after final treatment

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237547


Locations
Panama
Stem Cell Institute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
Principal Investigator: Nelson Novarro, MD

Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT02237547     History of Changes
Other Study ID Numbers: CNEI-2014-TBS-UCMSC-SCI001
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Translational Biosciences:
spinal cord injury
mesenchymal
bone marrow
mononuclear cells
stem cells
umbilical cord

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System