Shriners Hospitals for Children, Philadelphia Now Enrolling for Proneuron's Phase II ProCord Study

Business Wire, Nov 18, 2004

PHILADELPHIA -- The experimental ProCord procedure involves injecting specially treated autologous macrophages (type of white blood cell) into a patient's damaged spinal cord to help stimulate repair

Shriners Hospitals for Children, Philadelphia is now enrolling for Proneuron's Phase II trial of ProCord, for complete spinal cord injury. The official announcement was made at the Spinal Cord Injury Conference at Shriners Hospital in Philadelphia.

"Adolescents with spinal cord injuries have an opportunity to participate in this pivotal study for spinal cord regeneration. In addition to this experimental procedure, adolescents who come to Philadelphia will receive state-of-the-art medical, nursing and rehabilitation services and will be introduced to the spectrum of additional clinical and research programs available. This study represents Shriners Philadelphia Hospital's ongoing commitment to improving the physical, emotional and social health of children with traumatic, life changing injuries," stated Dr. Randal Betz, Chief of Staff, Shriners Hospital, Philadelphia.

Patients found eligible for the study will be randomly assigned to either a treatment or control group. Patients in the control group will not receive the experimental procedure. All control and treatment patients will receive standard spinal cord injury care and rehabilitation and will receive follow-up testing for one year.

This international, multi-center, randomized-controlled, experimental study is open to patients who meet eligibility criteria, including but not limited to an ASIA Grade A injury between C5-T11 vertebrae, within 14 days of injury. Asia Grade A is defined as patients who have no feeling or movement below the point of injury. Shriners Hospital is at liberty to enroll adolescents 16 years of age and older.

Patient, Immediate Family of Patient and/or Physician inquiries:
               24 hour a day Patient Recruitment Center:
                 E-mail: clinical.trial@proneuron.com
     Telephone: 1-866-539-0767 (U.S. toll free) or 1-506-652-3486.
                          Fax 1-866-214-7078

    (a) Callers outside the U.S., please use standard international
                             dialing code

             For additional information: www.proneuron.com

In addition to Shriners Hospitals for Children, Philadelphia the following sites are also enrolling patients in the ProCord study: University Hospital (Newark) in cooperation with Kessler Institute for Rehabilitation, West Orange, New Jersey; The Mount Sinai Medical Center in New York City; Craig Hospital in Denver, Colorado, and Chaim Sheba Medical Center in Israel. Shepherd Center in Atlanta, GA, also anticipated to begin enrollment in early 2005, is already taking an active role in the study as a referral and rehabilitation center.

About Shriners Hospitals for Children, Philadelphia:

Shriners Hospitals for Children, Philadelphia is a Center of Excellence in Pediatric Orthopaedics. The hospital is staffed by nationally and internationally known professionals specializing in providing medical and rehabilitative expertise to children with spinal cord injuries, orthopaedic spine deformities and, upper and lower extremity orthopaedic impairments. Through the expanded patient care programs at Shriners Hospitals, Philadelphia, including research and education, families with children with spinal cord injury and orthopaedic impairments have improved their quality of life.

Shriners Philadelphia Hospital is equipped and staffed to provide care for virtually all pediatric orthopaedic problems, with the exception of acute trauma. The hospital has developed a special expertise in the following areas: Spinal Cord Injuries, Cerebral Palsy, Scoliosis (curvature of the spine), brachial plexus injuries, Spina Bifida, Chest Deformities, Hand Disorders, Club Foot, Hip Disorders. All services are provided at no charge to the patient or family.

Shriners Hospitals for Children, Philadelphia is part of the Shriners Hospital System, which comprises 18 orthopaedic hospitals, three burn centers and one hospital in northern California, which specializes in both orthopaedics and burns, bringing the total to 22 hospitals in North America. The Philadelphia Hospital serves children primarily from the Mid-Atlantic States, but also those from the entire eastern coast of North America and the Caribbean Islands.

The Philadelphia Shriners Hospital is also a designated research center within the Shriners Hospitals healthcare system. In addition to the ProCord study for adolescents with newly acquired spinal cord injuries, Philadelphia Hospital is conducting spinal cord research to study the health benefits of functional electrical stimulation assisted cycling in young children with SCI, to evaluate the effectiveness of surgical interventions for improved hand and arm function in children with tetraplegia and to demonstrate the outcomes of activity based rehabilitation (combined cycling, swimming and treadmill training) in children with SCI of all levels.