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

Primary Purpose

Spinal Cord Injury

Status
Withdrawn
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
Sponsored by
Translational Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, mesenchymal, bone marrow, mononuclear cells, stem cells, umbilical cord

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stem Cell Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV and IT UC-MSC and BMMC

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients with adverse events
12 and 52 weeks after final treatment

Secondary Outcome Measures

Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
12 and 52 weeks after final treatment
Number of subjects with a change in Frankel Scale score from baseline
12 and 52 weeks from final treatment

Full Information

First Posted
September 9, 2014
Last Updated
August 8, 2017
Sponsor
Translational Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT02237547
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No enrollment.
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Biosciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
spinal cord injury, mesenchymal, bone marrow, mononuclear cells, stem cells, umbilical cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV and IT UC-MSC and BMMC
Arm Type
Experimental
Arm Description
Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
Intervention Type
Biological
Intervention Name(s)
Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
12 and 52 weeks after final treatment
Time Frame
12 weeks, 52 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
Description
12 and 52 weeks after final treatment
Time Frame
12 weeks, 52 weeks
Title
Number of subjects with a change in Frankel Scale score from baseline
Description
12 and 52 weeks from final treatment
Time Frame
12 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Novarro, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stem Cell Institute
City
Panama City
Country
Panama

12. IPD Sharing Statement

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

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