Trial Information

Summary: A study for patients with diagnosed complete spinal cord injury between C6 and T11.
Suitable patients will be transported to Belgium to undergo the experimental therapy. The treatment consists of taking blood and tissue from the patient, isolation and activation of macrophages in Proneuron's special facility, then surgical implantation administration of the autologous cells back to the patient by one of the participating neurosurgeons.

The patient will be required to remain in Belgium for approximately 3 months for follow-up evaluation and rehabilitation. Proneuron is willing to cover the costs for transporting the patient, and 3 months of medical costs including treatment, hospitalization and rehabilitation.

Patients are expected to return home after 3 months, but will be periodically assessed for at least a further 9 months by Proneuron-appointed staff. Proneuron will cover the costs of the assessments.

Inclusion criteria:

Age 16-65, male or female
Definitively diagnosed complete spinal cord injury at any level from C6 to T11 inclusive
Lesion confined to one spinal segment and location confirmed by MRI
Injury due to blunt, non-penetrating trauma
Can be treated within 21 days of injury
Exclusion criteria:
Coma or other severe neurological injuries or diseases
Unstable multiple trauma
Severe or infectious concurrent medical disease
Concurrent pregnancy
The Principal Investigator for this study is Prof. Jacques Brotchi, Head of Neurosurgery at the Erasme Hospital, Brussels

Contact:

Valentin Fulga, M.D.
Proneuron Biotechnologies
Located in:
Brussels, Belgium,
Telephone: +972 8 9409550
Fax: +972 8 9409560
Email: clinical.trial@proneuron.com