September 19, 2002
Latest Developments: On September 10, a biopsy was taken on the trial's second patient, a 29-year-old man with progressive-relapsing MS who received a transplant in March. No complications occurred, and the patient is reported to be doing well.
What's Next: The third patient will undergo a biopsy in approximately this Fall, after which the fourth and fifth patients will receive transplants.
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, under the direction of Drs. Timothy Vollmer and Marco Rizzo, is financed entirely by The Myelin Project.
The first patient, a 53-year-old woman with secondary progressive MS, was transplanted in July 2001, and underwent a biopsy in January. The trial's third patient, a 64-year-old woman with the primary progressive form of MS, was transplanted in April.
Thus far the research team has not seen any significant safety problems resulting from the transplantation 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.
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