The SituGen system enables doctors to more easily acquire stem cells for the treatment of diseases such as leukemia, cerebral palsy and brain injury. The umbilical cord is not just a baby’s lifeline until birth, but has also been proven to be a vital source of stem cells to treat life-threatening illnesses such as leukemia, cerebral palsy and brain injury – for the child itself, its adult family members and others. However, current methods used to extract the blood by the several dozen cord blood banks in the US are severely restricted by the fact that they can only extract enough blood to treat someone weighing up to 45 kg. (100 pounds).
BioCord, an Israeli start-up, has developed a novel method for collecting more than double this amount of blood from the umbilical cord, which means more illnesses can be treated and potentially more lives saved.
Their SituGen self-contained system does away with the current method of extracting the blood using a needle, which limits the amount of blood able to be extracted.
Storing cord blood is becoming more common in the US and worldwide since the first cord blood transplant in 1988. The blood is taken from the umbilical cord after the baby has been delivered and the cord cut and clamped but before the placenta emerges. Parents can pay to have the cord blood stored in a private cord blood bank, kept for their child and family members, or donate it anonymously to a public cord blood bank.
“Stem cells are taken from the cord blood and stored frozen in liquid nitrogen,” explains Miki Shacham, the CEO of Ramat-Gan-based Israeli cord blood bank BioCord and the inventor of the new device. “These are first of all for the baby itself, they are a one hundred percent match. But there is a high probability of a match with close family members.”
Stem cells are commonly taken from the bone marrow to treat diseases such as leukemia, but these stem cells are already mature; cord blood stem cells are much less mature, only nine months old, which means, says Shacham, “that they are more primitive and so they can become all types of cells,” useful for treating a variety of diseases, not just illnesses of the blood.
There are around 80 illnesses that are now being treated with these stem cells, Shacham told ISRAEL21c. The young age of the cord blood stem cells also means a lower match is needed with the donor cells to receive a stem cell transplant, compared with bone marrow stem cells. Embryonic stem cells are even younger and therefore more flexible, but harvesting embryonic stem cells is highly controversial in most countries worldwide.
The current method for extracting cord blood involves inserting a needle into the vein of the umbilical cord, and, keeping the placenta higher than the cord so that gravity pulls the blood downwards, the blood flows into a bag or a syringe, with the collector taking care not to contaminate it with the mother’s blood or bacteria from outside. However, although a skilled collector may be able to extract more, this method usually collects around 80 milliliters of the maximum 250 ml of blood generally present in the cord. There are roughly 80 to 100 million stem cells in 80ml, enough for someone who weights up to 100 pounds, a large child or a small adult.
“The major problem of cord blood banks is the amount of blood that is extracted,” says Shacham, an engineer who also holds an MBA. He decided to see what could be done.
The members of the R&D group headed by Shacham, which include stem cell pioneer Prof. Joseph Itzkoviz of the Rambam Medical Center’s department of obstetrics and gynecology in Haifa, Prof. Arnon Nagler of Tel Hashomer’s hematology department, Prof. Alexander Batler, head of cardiology at the Clalit health fund, and hematologist Prof. Eliezer Rachmilewitz, discovered that the problem lay in what happens to the blood a few minutes after birth.
“During clinical tests we collected [cord] blood, left it to stand for five minutes and then tried to pour it out,” says Shacham. But it wouldn’t pour – because it had already started thickening, or coagulating. “This starts happening minutes after birth [inside the cord],” he says. “With the current collection method used world-wide, you’re trying to extract the blood [with a needle] and it has already half-coagulated. It’s amazing how fast it happens. That is the problem and nobody recognized it. We now know that all those that were trying to solve the problem [of extracting more blood] were all wrong at the same point, they were making the same mistakes and assumptions.”
The half-millimeter needle that is inserted into the vein, which is several millimeters wide, simply can’t quickly and freely enough extract all the thickening blood. So Shacham and his team developed the SituGen which does away with the needle entirely.
Made mainly of polypropylene and latex, the SituGen comprises a holder which clamps around the umbilical cord, holding the cord in place as the placenta is delivered and absorbing the maternal blood so it doesn’t contaminate the baby’s cord blood. Attached to the holder through a sophisticated synchronization and sealing mechanism is a sterilization chamber into which the blood flows. A syringe is connected to the other end of the chamber which can be removed when full, emptied and then refilled.
“There’s no needle, there’s no bottleneck, it’s one hundred percent disinfected and sterilized, which is a must in this process,” explains Shacham.
In initial tests of the prototype, in around seven minutes as much as triple the usual 80ml was collected by the SituGen, enough stem cells to treat an adult. As well as extracting more blood, the device is easier to use than a needle, with only a short time needed to master its operation, says Shaham.
Shaham developed the device under the auspices of BioCord’s sister company, Impact, of which he is also the CEO. Not content with aiming to revolutionize cord blood collection, Shaham has another idea up his sleeve: a device for nursing mothers to allow them to measure exactly how much breast milk their baby has drunk. However, like every good businessperson, he is remaining tight-lipped about this until the prototype is ready and patents have been filed.
Once receiving the Rambam Medical Center Helsinki Committee approval, SituGen will be tested on around 50 patients over several weeks, although regulatory agencies such as the FDA don’t require such medical devices to undergo clinical trials. Patents application have been filed and Shacham is already in negotiations to market the SituGen, which is single-use and disposable and will cost around $100, through multinational companies that distribute cord blood bank products to the 150 or so cord blood banks around the world.
To fund marketing and production, he is raising $500,000 to add to the $500,000 invested by private investors and the Israeli Chief Scientist. “We are setting up a plant to produce the device in Israel,” he says. “Israel is very good at plastic moldings of medical devices.”