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Thread: First Proneuron Phase 1 clinical trial on activated macrophage transplants in subacute spinal cord injury

  1. #1

    First Proneuron Phase 1 clinical trial on activated macrophage transplants in subacute spinal cord injury

    According to Proneuron's web site on the trial ( ), the trial is recruiting patients that are between 18-65 years of age, male and female, complete spinal cord injury from C6-T11 from blunt non-penetrating trauma, and within two weeks after injury. Patients who are in coma, have unstable medical conditions, multiple trauma, and concurrent pregnancies are excluded.

    People from the United States can enter the trial. The treatment consists of obtaining blood, isolation of macrophages from the blood, exposure of the macrophages to skin obtained from the patient, and the surgical transplantation of the macrophages into the spinal cord at and around the injury site. The patients are expected to remain for 3 months of rehabilitation in Israel, Sheba Medical Center.

    Four patients have been entered into this trial to date. The first was Melissa Holley, a 19-year old woman from Colorado, who has recovered substantial motor and sensory function during the past 12 months after the transplant. The status of the other patients are unclear.

    According to Centerwatch ( ), Proneuron is willing pay for the cost of transportation, the treatment, and 3 months of hospital costs. Patients are expected to be followed up for 9 months after the transplantation.

    Contact information:
    Valentin Fulga, M.D.
    Chaim Sheba Medical Center
    Located in:
    Tel-Hashomer, Israel, 52621
    Telephone: +972 8 9409550
    Fax: +972 8 9409560

    [This message was edited by Wise Young on August 06, 2001 at 01:25 PM.]

    [This message was edited by Wise Young on Apr 10, 2002 at 04:39 PM.]

    [This message was edited by Wise Young on Apr 10, 2002 at 05:12 PM.]

  2. #2

  3. #3

    From Centerwatch

    Summary: A study for patients with diagnosed complete spinal cord injury between C6 and T11.

    Suitable patients will be transported to Israel 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 Israel 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 18-65, 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 14 days of injury
    Exclusion criteria:

    * Coma or other severe neurological injuries or diseases
    * Unstable multiple trauma
    * Severe or infectious concurrent medical disease
    * Concurrent pregnancy

    Valentin Fulga, M.D.
    Chaim Sheba Medical Center
    Located in:
    Tel-Hashomer, Israel, 52621
    Telephone: +972 8 9409550
    Fax: +972 8 9409560

  4. #4

    Newer criteria for the trial


    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:

    1. Patients must fully conform to inclusion/exclusion criteria detailed below.
    2. The patient must be less than 7 days after injury.
    3. 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.
    4. 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.
    5. The patient will return to his/her home country after 3 months.
    6. 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.

    Physicians treating eligible patients may send the details directly to
    Dr. Valentin Fulga, Fax: +972 8 9409560

    The contact address for general enquiries is here.

  5. #5

    Second Phase 1 trial announced by Proneuron

    Proneuron just announced a second phase 1 trial to be held in Erasme Hospital in Brussels, Belgium.

    See details and discussion at:

    In the new Belgian study, adults with a complete spinal cord injury in a segment from C6 to T11, and who can be treated within three weeks of their injury, may be eligible if they meet specified inclusion criteria. Macrophages are harvested from the patient, activated in a special facility and implanted surgically by the neurosurgeon. Following this procedure, patients will be intensively followed with safety monitoring and periodic assessments of neurological, radiographic and electrophysiological parameters. If results of the initial studies support additional clinical testing, a Phase 2 study will be initiated.

  6. #6
    Proneuron Completes Patient Recruitment for Its Phase 1 Clinical Trial for Complete Spinal Cord Injury; Patient Enrollment Continues for Additional Clinical Trial

    Story Filed: Wednesday, April 10, 2002 8:00 AM EST

    LOS ANGELES & NESS ZIONA, Israel, Apr 10, 2002 (BW HealthWire) -- Proneuron Biotechnologies Inc, today announced that it has reached its targeted eight patients for its Phase 1 clinical trial of activated autologous macrophage therapy for acute complete spinal cord injury (SCI). Follow-up of each patient continues for one year.

    Proneuron's clinical trial of the macrophage therapy began in 2000, under an 'Investigational New Drug' (IND) authorization from the US FDA and the Israeli Ministry of Health. Patients from the US, Europe and Israel participated in the study following the referral of leading hospitals. Those patients who met eligibility criteria were transported by Proneuron to Israel for administration of the experimental cell therapy and follow-up at the Sheba Hospital in Israel, before returning to their homes for long-term follow-up.

    Over the course of the trial, Proneuron has had enquiries from hundreds of prospective patients wishing to enroll in the study. Dr. Valentin Fulga, Proneuron's Senior VP of Development, noted the enormous effort that patients, their families and their referring physicians have made in helping to advance Proneuron's clinical investigation and a hope to continue and help others in return for their support.

    Dr. Daniel Lammertse, Medical Director of Craig Hospital in Colorado and President of American Spinal Injury Association, has followed the clinical progress of several of the Phase 1 trial subjects. Dr. Lammertse expressed cautious optimism for the potential of this treatment noting that, "the Phase 1 results suggest a positive treatment effect, giving clinicians hope that a new era of intervention is at hand."

    "So far there have been no serious adverse effects directly associated with the macrophage treatment. Furthermore, encouraging initial signs of some promising functional recovery have been observed in several patients. We are not aware of any other therapy with similar promising results," said Dr. Nachshon Knoller, Head of the Spine Unit at the Sheba Medical Center and principal co-investigator with Prof. M. Hadani.

    Proneuron is planning the next clinical study, which will be conducted at centers in the US, Europe and Israel. Meanwhile, Proneuron has opened a phase 1b trial in Belgium, with the approval of the Belgian authorities, for which it continues to recruit patients with complete SCI. Prof. Jacques Brotchi, Head of the Neurosurgery Service at the Erasme Hospital in Brussels, is the principal investigator.

    The use of activated macrophages for nerve regeneration is based on technology developed in the laboratory of Prof. Michal Schwartz, Weizmann Institute of Science, Israel and licensed to Proneuron. Prof. Schwartz and her team have made the initial discovery that activated macrophages induced neurological recovery in the damaged spinal cord of laboratory rats was the research basis for the development of the human clinical program.

    Details of the eligibility requirements and contact information can be found at About Proneuron
    Proneuron Biotechnologies, a Delaware company, is a privately held biopharmaceutical company developing products for treatment of spinal cord injuries and other acute and chronic disorders of the central nervous system based on proprietary technology for modulating the interaction between the nervous and immune systems. For more information visit

    CONTACT: Proneuron
    Valentin Fulga, M.D., +972-8-940-9550

  7. #7
    Some additional Melissa Holley links

  8. #8
    Craig hospital, Englewood, CO., will be the first center to offer this in the U.S. most likely some time in the spring 2003. Craig hospital; 303-789-8000

    Onward and Upward!

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