However, more profound burns may damage the limbal stem
cells from which the newest treatment derives its usage. For
those patients for whom stem cell therapy
is not an alternative the prognosis for these
cases can be very poor.
Graziella Pellegrini, co-author of the study is in charge
of the cell therapy unit at the Center for Regenerative
Medicine at the University of Modena and Reggio Emilia in
Modena, Italy. She claims that the new treatment involves
harvesting stem cells from the patient's healthy eye or from
the eyes of a relative or a friendly donor. Stem cells from
the patient's own eyes did not require the use of anti
rejection drugs. The corneal scars are removed and the
cultured material is transferred or grafted onto the injured
cornea in a manner similar to a contact lens. New cells are
further created which allows the cornea to start to return
to normal.
The researchers created enough cells in a lab culture and
then performed the transfer to 112 patients. Reports say
that the treatment was successful in 76.6% of the patients
and a partial success in 13.1% of the patients. Guidelines
for success indicate that all symptoms of light
sensitivity, itching and pain will have disappeared and a
new, healthy, transparent cornea will have developed. In
those cases in which there was no success (about 10.3%)
failure was due to surgical complications, or the profound
severity of the injuries.
The procedure succeeded after a single application
in 69% of the cases. A second procedure was needed for some
patients. Pellegrini said that half of those with deep
damage to the eye were able to enjoy restored vision. All of
the others were completely cured. The color and appearance
of the eye were normal in every respect. Her patients
were followed for an average of three years and some for as
long as a decade. Although there were no complications
during the grafting, postoperative adverse episodes in a few
of the patients included hemorrhage and residual fibrin on
the third postoperative day. There were also incidents of
inflammation, blepharitis with epithelial involvement and
herpetic keratitis.
The successful patients were euphoric and felt that
the results were miraculous. Dr. Pellegrini replies,
"It was not a miracle. It was simply a technique."
One of the successful stories involved a man who had severe
damage in both eyes as a result of chemical burns suffered
in 1948. Stem cells grafted from a small section of the left
limbal area were used to graft both eyes. His vision is now
close to normal.
The treatment may cost about $20,000 to $30,000. One
drawback to be considered is the unknown period of time that
the treatment will last. Some patients in this study did
well for a period of ten years. Currently, the stem cell
treatment is not approved in the U.S., but it is in use in
other countries. Pellegrini estimated that the new technique
may help 1,000 to 2,000 patients in Europe. Some areas
in Europe and developing countries are threatened by the
lack of regulations regarding the use of dangerous
chemicals. Therefore, the incidence of ocular accidents is
most likely to be higher in these locations.
The Italian study and presentation was praised by
Dr. Ivan Schwab, an ophthalmology professor and stem
cell expert at the Univ of California, Davis. He
claimed, "The Italian method is a roaring success.”
Unfortunately, there are reports that some researchers were
not having the same success as Pellegrini. Their
experience did not provide an enduring time of cure for
their patients. She feels that the stem cells extracted from
the limbus should be cultured in a proper mix with
differentiated cells that make up corneal tissue. If stem
cells are too few there will be no reserve to form the new
cells needed in the recycling mode that will enable the
results to last.
The stem cell culture increased and grew into
healthy tissue within a period of two weeks. Some regained
sight in two months. The deeper burns usually required a
second procedure and patience was rewarded after a year
when sight was finally restored. Dr. Schwab adds that a
hospital in India has joined the small group involved with
limbus derived stem transplants. He further states,
"The applications of this work may extend to other
organs. This is bigger than just the surface of the eye.
Pellegrini may be making a model for how to regenerate
livers and other organs." The study was partly funded
by the Italian government. The U.S. research is
centering attention on new ways to use self supplied stem
cells but feel that the work is still preliminary. In the
year 2008 there were 2,850 work related chemical burns to
the eye according to the US Bureau of Labor Statistics.
For decades, adult stem cells have been used to treat
leukemia and sickle cell anemia. Other stem cell studies
involve researching therapy for diabetes, bladder, liver and
heart failure, but have been met with limited success.
Dr. Schwab, with a twinkle in his eye, says, "After
all, we are not talking about regenerating the entire liver
or heart. The concept that you have to grow a whole liver or
a whole heart is a result of wild imagination and
should not be taken seriously." It should be pointed
out that adult stem cells are derived from different
parts of the body. Embryonic stem cells are found in human
embryos. The latter activity has caused much ethical
concern. Until this time the common therapy for
significant corneal burns is to utilize a corneal transplant
procedure.
However, complications have been recorded regarding
infection and glaucoma. A case of last resort
involves the use of stem cells obtained from a cadaver.
This is not considered a prime choice of treatment by our
doctors, as well as the patients. Dr. Sophie Deng is a
cornea expert at the UCLA's Jules Stein Eye Institute. She
observed that the Italian procedures created a big
advantage in their amazing progress since they were able to
increase the number of cells in the lab. This is less
invasive and lowers the chance of injury to the eye.
Dr. Ivan Schwab concludes, "Despite recent successes
in Italy, it's likely to be years before American doctors
again try to restore people's eyesight with stem cell
transplants. To those who have suffered with chemical burns
of the cornea, I don't want to give the false hope
that this will be the answer to their prayers. There are
steep regulatory and financial requirements for doing stem
cell corneal transplants. I just don't think that these
techniques are going to be available to patients in the
United States for a bit... maybe a decade.”