Medical Device Daily Contributing Writer

MARGATE, Florida — Cryo-Cell International (Oldsmar, Florida) and Plureon (Winston-Salem, North Carolina) recently were involved in demonstrating the collection and preservation of both cord blood and placental tissue for capture and culture of stem cells. The presentation was made in a webcast, combining a panel discussion with a live Caesarian Section delivery by Bruce Zafrin, MD, and his team of obstetrical surgeons.

Importantly, non-controversial placental stem cells have the potential to treat a host of diseases and disabilities.

Mercedes Walton, CEO and chairman and CEO of Cryo-Cell, moderated the panel that included Julie Allison, technical laboratory director of Cryo-Cell, Hal Eason, president of Plureon, and Jerry Maass, executive vice president of Cryo-Cell.

Opening the webcast, Walton, said that Zafrin and his team would “perform and describe the procedure as Rosa and Matt become first-time parents” from the delivery room. “Dr. Zafrin will then demonstrate a unique collection of stem cells and cord blood for use in regenerative medicine. This is truly cutting edge technology.”

Zafrin described the C-section in progress, “We are making a bikini incision into the abdomen using electrosurgical energy to dissect fat and small vessels down to the muscle layer. This entire procedure takes just a few moments.” He then demonstrated entering the abdominal cavity. “Rosa,” he said to the expectant mother, “don’t’ worry. You’ll soon be a size 2 again.”

The fascial layer was reached and incised. The patient was awake and under spinal anesthesia. Expectant father Matt was in the OR, taking pictures.

“Rosa, are you feeling OK,” Zafrin asked. She answered, “Yes.” “You’re going to feel a little pressure and soon you’ll meet little Emily,” explained Zafrin. The peritoneum was entered, the bladder retracted and the uterus could be seen. An incision was made into the uterine wall, the amnionic fluid suctioned out of the way, and the infant was delivered. After suction of the nose and mouth a strong, healthy cry ensued. The baby was handed off to a team of pediatric nurses.

Zafrin then directed the collection of cord blood samples.

“Here we take the clamped cord, clean it off first while the placenta is still in utero. First alcohol, then Betadine. A needle is placed in the umbilical vein, and we drain off about 150 ml of cord blood to collect stem cells. We have about two to three minutes to get this done before the placenta begins to separate from the uterus.” The umbilical cord blood was drained into a container off the sterile field. The container was then prepared for shipment to Cryo-Cell.

The surgeons then gently delivered the patient’s placenta and placed it in a sterile basin. Zafrin moved to a separate sterile field to prepare the tissue for shipment. Meanwhile the patient’s wound was closed and dressed in the traditional manner.

Zafrin explained, “This is a very simple method for obtaining cells. The placenta is a magical invention of nature. For the baby, the placenta provides oxygen and takes waste materials from the baby’s blood. The placenta is an absolute work of genius. Here, you can see a confluence of arteries and veins. This is called the arbor vitae —tree of life].

“We clean a 7 by 7 cm square area with alcohol, then Betadine. We use a sterile ruler to measure the area we need to sample. Now we collect the specimen by cutting through the placenta’s fetal surface down the full thickness of the placenta. We then place this sample in a sterile container with a buffer solution.” The tissue was then sealed, labeled and prepared for shipment to Cryo-Cell.

Allickson then explained what happens at the Cryo-Cell laboratory.

“This is a film of the techniques we use to manage the tissue samples when they arrive,” she noted. The processing methods were demonstrated. Quality assurance techniques and documentation were explained.

“In the end, the stem cells extracted from the cord blood and from the placenta are stored at -190 C and can be held indefinitely,” she said. Eason then elaborated on the properties of plureon stem cells.

“Plureon stem cells are very potent, early-stage stem cells first discovered at Children’s Hospital Boston several years ago. They are in between embryonic stem cells and adult cells. As the infant is developing, these cells are sloughed off in amniotic fluid and settle in the placenta. They remain suspended there until the birth. Plureon cells have a high pleuropotentiality. That is, they can become many other cell types. They have high proliferative potential. That is, they are easy to grow in culture. And, they are safer, less wild than embryonic cells.”

A question from the viewing audience, via e-mail: “How long can the plureon cells be kept?”

Allickson said they can be stored indefinitely “as can cord blood, as long as proper techniques are used. It’s like they go to sleep in cry and are later brought back to life. Sort of ‘Sleeping Beauty’ cells.”

Zafrin added: “I find this fascinating. There are 4 million births in the U.S. each year. Right now, probably 99% of all the placental tissue is discarded as medical waste. This process has a lot of therapeutic potential.”

Eason explained more about Plureon.

“We established the firm in 2002. Our strategy is to bring world class researchers, sponsors of research and biomedical technology companies together. We believe the therapeutic future is very promising. We have initiated a relationship with BD ([Becton, Dickinson & Co., Franklin Lakes, New Jersey] for research in diabetes, and we have achieved similar proof-of-principal in other disease types. We are very encouraged by the prospects of treating a variety of diseases.”