Embargoed for Release on September 10, 2001: Human Fetal Tissue Transplants Suggest Potential For Spinal Cord Repair, Reports Journal of Neurotrauma

rdf · 09-05-2001, 05:55 PM

LARCHMONT, N.Y.--(BUSINESS WIRE)--Sept. 4, 2001--A preliminary report of fetal spinal cord tissue transplantation in two patients with posttraumatic syringomyelia suggests that the procedure is both feasible and safe in humans, setting the stage for future research efforts in seeking better treatments for spinal cord injuries. The results, part of a four-year study, are described in a pair of papers in Volume 18, Number 9, of Journal of Neurotrauma, a peer-reviewed journal published monthly by Mary Ann Liebert, Inc. (http://www.liebertpub.com/neu].

The clinical study was based on a long history of laboratory research showing that transplants of embryonic nerve tissue in laboratory animals could achieve partial anatomical and functional repair following spinal cord injury (SCI). To determine whether this strategy could be successfully translated to humans, a pilot safety and feasibility study was initiated in 1997 in a group of eight patients with progressive posttraumatic syringomyelia. The study was conducted by a team of neuroscientists and clinical investigators from the University of Florida's College of Medicine, College of Health Professionals, and Evelyn F. & William L. McKnight Brain Institute, and the Malcom Randall Veterans Administration Medical Center, all in Gainesville.

"Feasibility and Safety of Neural Tissue Transplantation in Patients with Syringomyelia" was authored by Edward D. Wirth III, M.D., Ph.D.; Paul J. Reier, Ph.D.; Richard G. Fessler, M.D.; Floyd J. Thompson, Ph.D.; Basim Uthman, M.D.; Andrea Behrman, Ph.D.; Joella Beard, M.D.; Charles J. Vierck, Ph.D.; and Douglas K. Anderson, Ph.D. "Neurophysiological Assessment of the Feasibility and Safety of Neural Tissue Transplantation in Patients with Syringomyelia" was written by Thompson, Reier, Uthman, Susan Mott, M.D., Fessler, Behrman, Mark Trimble, Ph.D., Anderson, and Wirth. Both papers are available free online [9/10] at http://www.liebertpub.com/neu.

Syringomyelia is a painful and troublesome complication of SCI characterized by the formation of long cysts in the spinal cord, leading to further tissue damage and neurological problems. The reports published in Journal of Neurotrauma present findings for the first two patients in the study, men aged 44 and 51. For 18 months following transplantation surgery, both patients were stable neurologically, and magnetic resonance imaging showed evidence suggesting solid tissue at the graft sites without indications of donor tissue overgrowth.

The study's primary goal is to evaluate the safety of the transplantation procedure with respect to possible early complications and long-term consequences. Although data from the study authored by Wirth and others suggest that transplantation of fetal spinal cord tissue into syringomyelia cavities is logistically feasible and procedurally safe, the long-term consequences of graft survival are still uncertain, say the authors. A secondary goal, addressed in the paper by Thompson and others, is to establish a more comprehensive diagnostic protocol, ranging from neurophysiological tests that monitor subclinical function to standardized questionnaires that measure patients' quality of life.

"We didn't set out to find a cure," said Dr. Anderson. "We wanted to prove that fetal spinal cord transplantation was feasible and procedurally safe, and I think we've done that. We have also provided a template for future studies, which is extremely important. We now have a better idea of how to put these studies together, how to evaluate these patients, and what kinds of outcome measurements to include."

"Before this, there wasn't a lot going on translationally in spinal cord injury," said Dr. Wirth. "Sometimes it takes a study like this to break the ice. We're hoping it will show that with the proper preliminary data these kinds of studies are possible."

"Studies such as these are also important because they take us from the lab bench to the bedside and put us on an important learning curve about human spinal cord injury," added Dr. Reier. "They help us identify practical issues in the development of new and safe treatments. In that sense, this experience is already helping us design future laboratory studies that are more in line with real clinical conditions."

Donor tissue for the study was human fetal spinal cord tissue of six to nine weeks gestational age, procured following elective abortions in accordance with federal and state laws and ethical guidelines, with informed consent for donation. Dr. Reier pointed out that although such fetal cells are very unlikely to be the tissue source of choice for future treatments involving cell grafting in the spinal cord, "They still represent an important research tool in the study of spinal cord injuries and a benchmark for many other types of transplant material now being studied."

"Many questions regarding graft sources, long-term graft survival, growth, and safety still must be addressed," said Journal of Neurotrauma Editor-in-Chief John T. Povlishock, Ph.D., of the Medical College of Virginia of Virginia Commonwealth University. "Yet these early results are encouraging because they illustrate the potential of tissue transplantation for the stabilization and possible repair of central nervous system damage in humans."

Journal of Neurotrauma publishes peer-reviewed papers and reviews on the latest advances in both the clinical and laboratory investigation of traumatic brain and spinal cord injury, focusing on the basic pathobiology of injury to the nervous system while considering preclinical and clinical trials targeted at improving both the early management and long-term care and recovery of traumatically injured patients. It is the Official Journal of the National Neurotrauma Society and the International Neurotrauma Society and is indexed in Index Medicus/MEDLINE. To view the complete table of contents and authors, a listing of editorial board members, and a free sample issue, or to subscribe, visit http://www.liebertpub.com/neu.

Mary Ann Liebert, Inc., is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in new and promising areas of science and biomedical research, including Cloning & Stem Cells, Regenerative Medicine, Human Gene Therapy, and the book Biophysical Neural Networks: Foundations of Integrative Neuroscience. Its biotechnology trade magazine, Genetic Engineering News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 60 journals, books, and newsletters is available at http://www.liebertpub.com.

CONTACT:

Mary Ann Liebert, Inc.

Vicki Cohn, 914/834-3100, ext. 617

fax: 914/834-4329

vcohn@liebertpub.com

KEYWORD: NEW YORK MASSACHUSETTS

Jeff · 09-05-2001, 06:24 PM

Most of us, I think, view it largely as a bust. We were hoping for a cure which we didn't get. But, if you're losing function due to a syrinx, you really did find a cure. Plus, proving the safety of cell/tissue grafts is immensely important. I'm sure this study has paved the way for many of the upcoming ones.

09-05-2001, 05:55 PM	#1
rdf Senior Member Join Date: Jul 2001 Location: Someplace between Nowhere and Goodbye Posts: 12,610	Embargoed for Release on September 10, 2001: Human Fetal Tissue Transplants Suggest Potential For Spinal Cord Repair, Reports Journal of Neurotrauma LARCHMONT, N.Y.--(BUSINESS WIRE)--Sept. 4, 2001--A preliminary report of fetal spinal cord tissue transplantation in two patients with posttraumatic syringomyelia suggests that the procedure is both feasible and safe in humans, setting the stage for future research efforts in seeking better treatments for spinal cord injuries. The results, part of a four-year study, are described in a pair of papers in Volume 18, Number 9, of Journal of Neurotrauma, a peer-reviewed journal published monthly by Mary Ann Liebert, Inc. (http://www.liebertpub.com/neu]. The clinical study was based on a long history of laboratory research showing that transplants of embryonic nerve tissue in laboratory animals could achieve partial anatomical and functional repair following spinal cord injury (SCI). To determine whether this strategy could be successfully translated to humans, a pilot safety and feasibility study was initiated in 1997 in a group of eight patients with progressive posttraumatic syringomyelia. The study was conducted by a team of neuroscientists and clinical investigators from the University of Florida's College of Medicine, College of Health Professionals, and Evelyn F. & William L. McKnight Brain Institute, and the Malcom Randall Veterans Administration Medical Center, all in Gainesville. "Feasibility and Safety of Neural Tissue Transplantation in Patients with Syringomyelia" was authored by Edward D. Wirth III, M.D., Ph.D.; Paul J. Reier, Ph.D.; Richard G. Fessler, M.D.; Floyd J. Thompson, Ph.D.; Basim Uthman, M.D.; Andrea Behrman, Ph.D.; Joella Beard, M.D.; Charles J. Vierck, Ph.D.; and Douglas K. Anderson, Ph.D. "Neurophysiological Assessment of the Feasibility and Safety of Neural Tissue Transplantation in Patients with Syringomyelia" was written by Thompson, Reier, Uthman, Susan Mott, M.D., Fessler, Behrman, Mark Trimble, Ph.D., Anderson, and Wirth. Both papers are available free online [9/10] at http://www.liebertpub.com/neu. Syringomyelia is a painful and troublesome complication of SCI characterized by the formation of long cysts in the spinal cord, leading to further tissue damage and neurological problems. The reports published in Journal of Neurotrauma present findings for the first two patients in the study, men aged 44 and 51. For 18 months following transplantation surgery, both patients were stable neurologically, and magnetic resonance imaging showed evidence suggesting solid tissue at the graft sites without indications of donor tissue overgrowth. The study's primary goal is to evaluate the safety of the transplantation procedure with respect to possible early complications and long-term consequences. Although data from the study authored by Wirth and others suggest that transplantation of fetal spinal cord tissue into syringomyelia cavities is logistically feasible and procedurally safe, the long-term consequences of graft survival are still uncertain, say the authors. A secondary goal, addressed in the paper by Thompson and others, is to establish a more comprehensive diagnostic protocol, ranging from neurophysiological tests that monitor subclinical function to standardized questionnaires that measure patients' quality of life. "We didn't set out to find a cure," said Dr. Anderson. "We wanted to prove that fetal spinal cord transplantation was feasible and procedurally safe, and I think we've done that. We have also provided a template for future studies, which is extremely important. We now have a better idea of how to put these studies together, how to evaluate these patients, and what kinds of outcome measurements to include." "Before this, there wasn't a lot going on translationally in spinal cord injury," said Dr. Wirth. "Sometimes it takes a study like this to break the ice. We're hoping it will show that with the proper preliminary data these kinds of studies are possible." "Studies such as these are also important because they take us from the lab bench to the bedside and put us on an important learning curve about human spinal cord injury," added Dr. Reier. "They help us identify practical issues in the development of new and safe treatments. In that sense, this experience is already helping us design future laboratory studies that are more in line with real clinical conditions." Donor tissue for the study was human fetal spinal cord tissue of six to nine weeks gestational age, procured following elective abortions in accordance with federal and state laws and ethical guidelines, with informed consent for donation. Dr. Reier pointed out that although such fetal cells are very unlikely to be the tissue source of choice for future treatments involving cell grafting in the spinal cord, "They still represent an important research tool in the study of spinal cord injuries and a benchmark for many other types of transplant material now being studied." "Many questions regarding graft sources, long-term graft survival, growth, and safety still must be addressed," said Journal of Neurotrauma Editor-in-Chief John T. Povlishock, Ph.D., of the Medical College of Virginia of Virginia Commonwealth University. "Yet these early results are encouraging because they illustrate the potential of tissue transplantation for the stabilization and possible repair of central nervous system damage in humans." Journal of Neurotrauma publishes peer-reviewed papers and reviews on the latest advances in both the clinical and laboratory investigation of traumatic brain and spinal cord injury, focusing on the basic pathobiology of injury to the nervous system while considering preclinical and clinical trials targeted at improving both the early management and long-term care and recovery of traumatically injured patients. It is the Official Journal of the National Neurotrauma Society and the International Neurotrauma Society and is indexed in Index Medicus/MEDLINE. To view the complete table of contents and authors, a listing of editorial board members, and a free sample issue, or to subscribe, visit http://www.liebertpub.com/neu. Mary Ann Liebert, Inc., is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in new and promising areas of science and biomedical research, including Cloning & Stem Cells, Regenerative Medicine, Human Gene Therapy, and the book Biophysical Neural Networks: Foundations of Integrative Neuroscience. Its biotechnology trade magazine, Genetic Engineering News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 60 journals, books, and newsletters is available at http://www.liebertpub.com. CONTACT: Mary Ann Liebert, Inc. Vicki Cohn, 914/834-3100, ext. 617 fax: 914/834-4329 vcohn@liebertpub.com KEYWORD: NEW YORK MASSACHUSETTS

09-05-2001, 06:24 PM	#2
Jeff Senior Member Join Date: Jul 2001 Location: North Brunswick, NJ, USA Posts: 6,858	This study was extremely important Most of us, I think, view it largely as a bust. We were hoping for a cure which we didn't get. But, if you're losing function due to a syrinx, you really did find a cure. Plus, proving the safety of cell/tissue grafts is immensely important. I'm sure this study has paved the way for many of the upcoming ones.

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