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

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