Proneuron is currently recruiting
patients for a Phase 1 study on complete spinal cord injury.
August 9, 2000
NESS ZIONA, Israel,
Proneuron is recruiting worldwide for up to 8 patients in a
Phase 1 clinical trial in Israel of an experimental therapy
for Complete Spinal Cord Injury. Patients who have suffered
Acute Complete Spinal Cord Injury within the last 7 days, may
provide their treating physician with the following eligibility
information. Suitable patients will need to be transported to
Israel to undergo the experimental treatment. The patient will
be required to remain in Israel for approximately 3 months for
follow-up evaluation and rehabilitation.
Eligibility criteria:
- Patients must fully conform to inclusion/exclusion criteria
detailed below.
- The patient must be less than 7 days after injury.
- An MRI showing the injury must be sent (preferably by
e-mail) to Proneuron before the patient is accepted, or
the radiologist could be in direct contact with one of the
treating neurosurgeons to discuss details.
- To ensure the patient's agreement to participate in
the study, he/she will sign the Informed Consent form before
he/she is accepted and again in Israel before the procedure
is performed.
- The patient will return to his/her home country after
3 months.
- During the following 9 months, the patient must be available
for further assessments (performed in his/her home country
by Proneuron's representatives).
Inclusion criteria
- Age between 18 and 65.
- Male or non-pregnant non-lactating female.
- Individuals who have suffered a definitively diagnosed
complete spinal cord injury.
- A single spinal cord lesion in the segment from C6 to
T11.
- The location of the injury can be determined by MRI
as the region of the bony defect.
- The spinal cord injury is due to blunt, non-penetrating
trauma.
- Can be treated before 14 days have elapsed after the
injury.
- Informed consent obtained and consent form signed.
Exclusion criteria
- Coma (that may interfere with the clinical evaluation
of the patient).
- Penetrating spinal cord injury (to exclude potential
risk of infection).
- Patient who received blood transfusions during the immediate
period (three days) prior to the spinal cord injury (to
exclude the potential of non-autologous monocytes in the
harvested blood).
- Unstable multiple trauma that:
- Requires continuous therapy (at the time of experimental
treatment) with pressor drugs such as vasoactive amines.
- Involves risk of septicemia.
- Presents a surgical risk, such as liver, lung or
kidney failure.
- Causes the patient to be unable to tolerate harvesting
of 200 ml blood.
- Severe concurrent medical disease (e.g., septicemia,
HIV/HBV/HCV infections, insulin-dependent diabetes mellitus,
systemic lupus erythematosus, multiple sclerosis, amyotrophic
lateral sclerosis, malignancy).
- Chronic immunomodulating or cytotoxic drugs treatment.
- Anemia (hemoglobin lower than 10 gr. %), or after significant
hematological disorder.
- History of severe neurological diseases or any other
disease that may interfere with the neurological examination.
- Other severe neural injuries.
- Patient unlikely to be available for follow-up.
Contact:
Dr. Valentin Fulga - Senior VP Clinical & Regulatory Affairs
at the following numbers:
+972-8-9409550 (in Israel)
+972-50-762140 (in Israel)
Email:
valentin@proneuron.com
