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

NCT ID: NCT02237547

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-10-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV and IT UC-MSC and BMMC

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Interventions

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Translational Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelson Novarro, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Stem Cell Institute

Panama City, , Panama

Countries

Panama

Other Identifiers

CNEI-2014-TBS-UCMSC-SCI001

Identifier Type: -

Identifier Source: org_study_id