April 29, 2002
Background: This is a five-patient, Phase I clinical trial at Yale University School of Medicine to assess the viability and safety of transplanting Schwann cells into the brain of patients with multiple sclerosis. Schwann cells are the cells that produce myelin in the peripheral nervous system (in contrast to oligodendrocytes, the myelinating cells in the central nervous system). This trial uses autologous transplantation, meaning the cells are harvested from the patients themselves, in this case from the ankle. The study, led by Dr. Timothy Vollmer, is financed entirely by The Myelin Project.
Latest Developments: On April 25, 2002, researchers transplanted the trialís third patient, a 64-year-old woman with the primary progressive form of MS. The second patient, a 29-year-old man with progressive-relapsing MS, was transplanted in March 2002. The first patient, a 53-year-old woman with secondary progressive MS, was transplanted in July 2001, and underwent a biopsy in January 2002.
The research team has not seen any significant safety problems resulting from the transplantion procedures. This is in itself an important result, one that will encourage other laboratories around the world to undertake similar trials of Schwann cell transplantation. However, the researchers have not obtained so far any direct evidence of remyelination. The study was designed so that a relatively small number of cells was transplanted in the first patient. The amount was increased in the second and third patients, with greater amounts to be transplanted in the last two patients.
What's Next: The second and third patients will undergo a biopsy in approximately six months, after which the fourth and fifth patients will receive transplants.
Applicability to Other Demyelinating Disorders: Should the Schwann
cell transplantation approach prove effective in MS, this could pave the
way for replicating the procedure in other demyelinating diseases, either
with the use of Schwann cells, or with other cell types. The Myelin Project
is currently financing studies on both sides of the Atlantic of other types
of myelin-forming cells that have potential for transplantation, among
them olfactory ensheathing cells and oligodendrocyte precursors derived
from stem cells.
© 2002, The Myelin Project