Favoring the foresaken foreskin
An Australian-born Jew who spent 20 years searching for a treatment for his son's painful skin condition found supplies of the essential ingredient in an ancient rite - circumcision
For millennia, explanations have been put forward for the ancient Jewish practice of ritual circumcision, which is performed on every Jewish male when he is eight days old. According to the Bible, circumcision is a token of the unique covenant between God and the Jewish people. What's more, the Web site www.circumcision.net states that the "fact that circumcision is performed on the sexual organ is significant. This organ is representative of the body's urges and this procedure indicates that we must control and sublimate these urges and conform them to the Will of God."
Today, however, circumcision is being used for a purpose that the rabbis of antiquity probably never anticipated: to treat skin wounds such as burns, venous and diabetic ulcers and a rare hereditary skin disease, epidermolysis bullosa (EB), which causes intense peeling and blistering of the skin.
Ortec International, a tissue-engineering company based in New York City, has developed a wound dressing, Orcel, comprised of human skin cells that are harvested and grown from foreskins removed during circumcision. Orcel, which is applied by being spread over the wound and covered with a protective dressing, causes the body to recreate its own wound-healing environment, thereby stimulating the patient's own skin to heal itself, the company says.
According to Dr. Mel Silberklang, Ortec's vice president of research and development, "Newborn skin has healthier, more vigorous cells than older skin, so newborn skin is the best skin [to use to produce Orcel]." But can skin from other parts of the body besides the foreskin be used to generate Orcel? In principle, you could use skin from other parts of the body, says Dr. Silberklang. "But I don't know anybody who's donating any."
That, of course, is where the mohel, or ritual circumciser, comes in. Ortec has arranged that a local mohel will provide the company with a foreskin whenever it is needed. As of now, though, that need is not particularly great. One foreskin - once the cells have been grown and multiplied in Ortec's laboratories - is capable of producing about 10,000 to 15,000 product units. As such, Ortec currently uses only one foreskin a year.
Given, however, Ortec's recent successes marketing Orcel, that requirement may change. This past February, Ortec, which was founded in 1991, finally received approval from the Food and Drug Administration (FDA) in the U.S. to market Orcel for use in patients with EB. And this past July, Ortec received a unanimous recommendation for approval from the General and Plastic Surgery Devices Advisory Panel of the FDA for the use of Orcel in the treatment of burn victims. Ortec expects final FDA approval by this fall. Thus, with the commercialization of Orcel, Ortec may require as many as 10 foreskins a year.
"We've had people who have asked to be involved in this process of donating the orlah [foreskin] of their newborn child to our company," Steven Katz, the chairman, CEO and co-founder of Ortec said. "The mohel has got parents lined up who are actually very disappointed that we don't need that many orlahs, because these parents are eager that the first mitzvah of their child should be to help other people."
Orcel's approval by the FDA represents a significant accomplishment for Ortec, which after years of research and growth has now at last begun to see at least the partial fulfillment of its raison d'etre. But Ortec still has a lot of work ahead. For starters, over the coming months and years Ortec hopes to receive FDA approval for the use of Orcel to treat venous and diabetic skin ulcers, and is conducting clinical trials toward that end.
Once Orcel is commercially available, it should satisfy a pressing need for remedies for skin disorders, according to the company. In the United States alone, there are some 10,000 EB patients, 4,000 of whom have severe cases; a million individuals suffering from burns, only 53,000 of whom are hospitalized; 700,000 individuals with venous ulcers; and 800,000 patients with diabetic ulcers.
The story of Ortec's founding is a story of one man's struggle, sacrifice and trial and error for years, in a desperate attempt to save the life of his son.
"This child was born for a reason," Rabbi Aaron Shapiro said, referring to his grandson Ari Eisenberg, who was born in 1971 with epidermolysis bullosa.
Watching his newborn son writhing and screaming in pain as a result of the crippling EB, Ari's father Mark Eisenberg, an Australian medical doctor and Holocaust survivor, knew he could not just stand by and wait for his son to die. At the time, EB was a virtually unheard of disease with no known cure, but Dr. Eisenberg decided that he was going to find one.
Dr. Eisenberg ended up spending more than 20 years of his life devoted to this effort. He traveled around the world, doing research at various universities and attending medical conferences. He spent hours a day in the laboratory, somehow managing to juggle his time between his research and taking care of Ari, who required around-the-clock attention.
Even the slightest cut or scrape could be life threatening for Ari, Rabbi Shapiro recalled. Indeed, when three years old, Ari was taking a walk with his mother Rochelle one day, when he suddenly tripped and fell. To Rochelle's horror, his hand was completely denuded - no skin remained. Although he suffered tremendous pain, Ari's life soon returned to normal - normal for an EB patient, that is - but it was incidents like these that encouraged Dr. Eisenberg to intensify his research efforts.
His first major breakthrough came when he ascertained that a drug called Dilantin, for epilepsy, could actually inhibit the production of blisters. Later, he developed what is now known as Orcel, which was created from skin cells harvested from foreskins. Then, Dr. Eisenberg performed surgical procedures on about 20 children with skin disorders - including a surgical procedure on Ari's hands - in which Orcel was applied.
When the bandages were removed from Ari's hands after the surgery, he was astonished to discover two perfectly formed hands, without blistering or scarring, the rabbi said. The Orcel had worked: Ari could now shake people's hands and use his hands for other normal daily functions without having to worry about blisters, scars or peeling skin.
In 1990, Dr. Eisenberg approached Dr. Katz, a relative and businessman, for help with financing the production of Orcel. Dr. Eisenberg was at Katz's home, telling him about his latest developments in his research and his surgical procedures performed using Orcel. "We were relatives for 33 or 34 years," said Dr. Katz. "So when Ari Eisenberg was born about 30 years ago, I knew of the birth, I knew of the tzara [trouble] that they had.
"He asked me if I could help him. I felt this was an opportunity to do some good, [so] that's when I suggested we form a company, and I raised the funds commercially for this project."
Thus, in 1991, Ortec International became a reality. Today, Ortec is a thriving, $55-million dollar, publicly-traded company that has received substantial recognition from the medical community. In fact, in early 2000, Frost & Sullivan, an influential marketing consulting company, presented Ortec with its 1999 Market Engineering Leadership Product Innovation Award and its 1999 Market Engineering Leadership Award for Entrepreneurial Companies.
"Any physician that's used our product and knows what the options are, is very excited about our product," Dr. Katz said.
As for Dr. Eisenberg, it is unlikely that he could ever have foreseen the enormous medical advancements that resulted from his passionate struggle to save his son. Thousands of people who suffer from skin disorders may now benefit from Dr. Eisenberg's work and the company that his singular efforts spawned.
But this story does not have an entirely happy ending. This past April, Ari died at the age of 30, from kidney failure, a disorder completely unrelated to the skin diseases from which he suffered for nearly all his life. Nonetheless, as his grandfather predicted, the Eisenbergs have truly left their mark on the world.
By arrangement with the Forward.