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

August 8, 2017 updated by: Translational Biosciences
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • Stem Cell Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: 12 weeks, 52 weeks
12 and 52 weeks after final treatment
12 weeks, 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks, 52 weeks
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
12 weeks, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Biosciences

Investigators

  • Principal Investigator: Nelson Novarro, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNEI-2014-TBS-UCMSC-SCI001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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