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

Translational Biosciences

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Spinal Cord Injury

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02237547

CNEI-2014-TBS-UCMSC-SCI001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts 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