Innovative Knee Surgery Relies on Transplant of Cells
Mark Piolatto, a strapping Palmdale man who not so long ago was a high school wrestling champ, a martial-arts black belt and an avid skier, has seldom taken a step in the last 10 years without pain.
After tripping and injuring his knee in 1987 at the Rockwell plant in Palmdale, where he was a machine operator, he underwent three operations for cartilage damage. But the relief was always temporary.
“There was no doubt, no doubt I would eventually be crippled,” the 38-year-old Piolatto said Friday as he lay in bed at Sherman Oaks Hospital and Health Center, just before his fifth operation.
But this was not to be another temporary fix, nor a run-of-the-mill surgery.
Piolatto was about to undergo a revolutionary procedure to transplant into his knee 30 million healthy cartilage cells that had been grown from his own tissue in a Massachusetts laboratory and flown in for the occasion. It was to be only the 11th surgery of its type in Southern California and about the 100th in the nation.
If the operation is successful, the transplanted cells will grow into a replacement for Piolatto’s damaged cartilage--in that case, he would not only walk without discomfort, his doctors say, he would even be able to compete in contact sports again.
The procedure, approved by the U.S. Food and Drug Administration only last year, is called articular chondrocyte implantation. It was developed about seven years ago in Sweden, where it has been 87% effective in treating knee injuries involving cartilage damage.
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A paper on the procedure was published in the New England Journal of Medicine in 1994, and the Harvard Health Letter named it one of the top 10 medical advances of the same year.
Although it is a breakthrough treatment for knee problems caused by injury--doctors estimate that there are thousands of such cases each year--it provides no aid for damage caused by arthritis and other inflammatory conditions.
But it marks a major advance from what was formerly the ultimate treatment for knee injuries--artificial knees, which offer only limited mobility, last for a maximum of 10 years and are not renewable.
“Once you do a total knee replacement,” said hospital spokeswoman Aimee Withem, “that’s it, that’s all they can do.”
“Except shoot you,” added Piolatto.
The knee cell transplant procedure, first performed at the University of Goteborg by surgeon Lars Peterson, is overseen in this country by Genzyme Inc., a Cambridge, Mass., company, which is licensed by the Swedish originators.
The key to the procedure is the ability to grow replacement cells from the patient’s own healthy cartilage in a laboratory.
“The ideal patient is a 54-or-younger, otherwise healthy individual,” said David Foster, a local representative for Genzyme who was on hand for the operation, the first for the hospital.
The procedure on Piolatto actually began three weeks ago, when bits of healthy cartilage were extracted in three small sections--which combined would be about half the size of a fingernail. These were shipped to Genzyme’s lab in Cambridge, where they underwent an enzyme process to strip away all but one ideal cell.
This cell was placed in a growing medium--the nature of which is a company secret, Foster said--to multiply.
“The surgeon tells us the size of the space they want to fill, and we figure out how much to make,” Foster said.
For Piolatto, the resulting number of cells was about 30 million, Foster estimated, which were flown back to Sherman Oaks in a vial not much bigger than those given out in department stores as perfume samples.
From there on, it was a race to get the cells into Piolatto’s knee. “They are only good for three days,” said Foster, “and we lose one [day] in shipping.”
The crucial timing is just one attribute of the procedure that makes health-insurance companies nervous.
“They say, ‘What if the patient gets sick?’ ” and the surgery must be delayed, said Debbie Cook, surgical coordinator for Domenick Sisto, the surgeon who performed the operation.
Although the procedure is FDA-approved, insurance companies are still reluctant to pay for it, she said. The total cost is about $25,000, of which $10,000 goes to Genzyme for growing the cells.
“We worked on this one for seven months to get the insurance approval,” said Cook, who was on hand for the surgery. “After all that, I wasn’t going to miss this.”
The hospital’s video crew was also on hand to record every detail. A few doctors stopped by to observe in person. Surgical suites are often filled with music during operations, but for this one, the room’s boombox sat silent. There was little of the joking and small talk that usually accompany routine procedures.
With Piolatto unconscious under a general anesthetic, an eight-inch incision bared the bones of his knee. Sisto, who was trained in the procedure in Boston and was doing it for the first time, located the injured section of cartilage, about the size of a quarter.
Always aided by at least three nurses, he cleaned out the area and traced its outline on a piece of paper with a marking pen.
A few inches lower, he made a smaller incision and cut a patch of skin matching the paper template.
All this took about an hour. Then, using a hook-shaped surgical needle, Sisto took another hour to painstakingly sew the skin patch over the injured area. Part of the way through, Sisto asked for a tall chair so that he could sit while sewing.
“I apologize, this is the time-consuming, boring part of the process,” he said to those present.
With the patch in place, Foster went to a plain cardboard box sitting by the door. From it he carefully lifted, with both hands, a plastic canister about the size of a coffee can and removed the orange lid. Inside, packed in blue insulation foam, was the vial.
Sisto stuck a plastic catheter into it and sucked the cells into a syringe. Inserting the catheter under the sewn-on flap, he injected the cells and sealed the stitches with an organic glue solution.
Nurse Dwayne McHenry turned to the crowd and said: “You can all exhale, again.”
“In six months,” Sisto said, sewing up the knee, “we’re all going to go skiing with this patient.”
(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)
A Growing Practice
New knee surgery technique grows patient’s own cells for cartilage replacement:
1. Healthy knee cartilage is sliced from non weight-bearing segment
2. Cells are removed, placed in a nourishment to stimulate growth. Increased both in size and number, cultured cells are returned to surgeon
3. Membrane is transplanted from lower leg bone and sutured on top of treated area
4. Cultured cells are injected into defective section
Source: Genzyme Tissue Repair; Researched by APRIL JACKSON / Los Angeles Times
