A Novel Umbilical Cord Blood Collection System.

Hematopoietic stem cell transplant procedures are limited by the availability of suitable matched donor cells. Banked, umbilical cord blood (UCB) is a favorable alternative stem cell source for transplantation therapy, due to the more primitive nature of stem cells in UCB and the ability to increase recruitment of donors of minority ethnic backgrounds. However, low collection volumes, the single most important factor for successful cord blood transplants, leads to discarding a large portion of UCB units. We report an improved method based on a single use, disposable device that allows semi-skilled personnel to collect UCB rapidly, aseptically, and without the need to utilize a needle puncture of the cord. This facilitates the safe and efficient collection of a greater number of acceptable UCB units.

The placenta and the attached umbilical cord were collected after delivery and transferred to a stand that allowed collection of UCB by gravitational force by either needle collection (n=40) or application of the new clamp/cutting/collection device (n=60). The device clamps around the cord providing a biological seal. The cord is subsequently severed by an internal blade and UCB is allowed to freely flow into the collection device and then into a blood collection bag. Alternatively, the umbilical vein in the cord was punctured by a needle. A typical variety of placenta and cord sizes was encountered. Using either method, blood was collected in standard collection bags. Ease of use, time of collection, and blood volume collected were compared. Nucleated cell and CD34 counts were obtained on the UCB units. The collection device, cord and placenta were discarded as biological waste. Collected UCB units were used for research purposes, and not stored for transplantation or any therapeutic purpose.

Application of the new device was straightforward; after closing cutting could be performed in one simple and fast movement. In contrast standard collection using venipuncture needed more careful attention. After start of the collection, UCB drained in 45± 10 (n=60) seconds from placenta and cord into the device, and subsequently into the standard collection bag within 3 ± 1 minutes. Needle collection required approximately twice as much time. The volume collected using the device (65–126 ml, 95±19 ml, n=60) compared favorably with the units collected with a needle (0–128 ml, 63±31 ml, n=40). Virtually identical concentrations of CD34 cells were found in units collected with both procedures. Since the average UCB volume increased with the new method, the average total number of CD34 cells per unit collected increased accordingly.

In conclusion, we developed a non-invasive needle-free device to ensure the safe, efficacious, and aseptic collection of UCB during normal birthing or after cesarean section. The ease of use, speed of collection and UCB volumes collected compare favorably with traditional methods. The design of the device prevents medical personnel from being exposed to blood borne disease from blood splashing and accidental needle sticks. Because no careful placement of needles is required, semi-skilled personnel can perform the procedure in place of physicians, nurses, and highly trained technicians, improving the UCB collection procedure with minimal interference in the childbirth setting, potentially increasing the number of UCB units collected.