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Frequently Asked Questions

Cord Blood Science

Cord blood is found in the blood vessels of a newborn’s umbilical cord. For more information about cord blood, please click here.

Cord blood is collected at birth after the baby has been delivered and the umbilical cord is clamped and cut. The collection can be done either when the placenta is still in the womb (in-utero) or outside of the womb (ex-utero).

Cord blood contains blood-forming stem cells which can be used for the life-saving treatment of autoimmune, neurological and metabolic disorders, such as leukemia.

The main limiting factor for cord blood transplantation is the number of cord blood stem cells available [1-6]. A minimum of twenty million cell per kilogram is typically needed for a transplant, this number increases in some diseases. A consequence of this is that most cord blood unit stored can only be used before adulthood. With CANULEX™, a higher yield of cord blood stem cells is achieved through our proprietary design which provides the following benefits:

  1. Better therapeutic outcome during transplantation
  2. Extends the use to adult patients
  3. Save more for other purposes

 

References

  1. Barker, J. N. et al. (2001). Survival after transplantation of unrelated donor umbilical cord blood is comparable to that of human leukocyte antigen-matched unrelated donor bone marrow: results of a matched-pair analysis. Blood, 97, 2957-2961.
  2. Barker, J. N. et al. (2002). Searching for unrelated donor hematopoietic stem cells: availability and speed of umbilical cord blood versus bone marrow. Biol Blood Marrow Transplant, 8, 257-260.
  3. Delaney, C., Ratajczak, M. Z., & Laughlin, M. J. (2010). Strategies to enhance umbilical cord blood stem cell engraftment in adult patients. Expert Review of Hematology, 3(3), 273–283.
  4. Laughlin, M. J. et al. (2001). Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med., 344, 1815-1822.
  5. Rocha, V. et al. (2001). Comparison of outcomes of unrelated bone marrow and umbilical cord blood transplants in children with acute leukemia. Blood, 97, 2962-2971.
  6. Wagner, J. E. et al. (2002). Transplantation of unrelated donor umbilical cord blood in 102 patients with malignant and nonmalignant diseases: influence of CD34 cell dose and HLA disparity on treatment-related mortality and survival. Blood, 100, 1611-1618.

A needle connected to a blood bag is typically used for the collection of cord blood. The doctor or nurse uses the needle to pierce into the umbilical vein of the umbilical cord and the blood is collected in the blood bag. The blood bag is then sent to a blood bank for processing and storage.

Using CANULEX™

Collection using CANULEX™ has an extended collection window which could increase the amount of cord blood stem cells and cord blood volume. A higher volume not only reduces the likelihood of a CBU being rejected but also improves the quality of the CBU.

Usage of CANULEX™ has not resulted in health concerns to the delivering mother and the baby. In fact, Canulex improve the safety of cord blood collection in comparison to the current method. Cord blood collection using Canulex significantly minimize the interruption to the labor process. Under the current method of cord blood collection, an in-utero collection requires a pause of 2 -3 minutes. This pausing interrupts with the obstetric workflow where medical procedures are delayed, which may put the mother at risk of postpartum hemorrhage.

CANULEX™ with its extended collection window based on the proprietary in-to-ex utero collection method helps to mitigate the effect of delayed cord clamping on the volume of cord blood collected.

CANULEX™ can be used solely for ex-utero collection or in-utero collection. However, CANULEX™’s special design allows the collection to be “in-to-ex utero” where a longer collection window allows more blood to be collected.

Production

Yes, the device is sterile.

CANULEX™ is designed and manufactured in Singapore under ISO 13485 standard.

Clinical trial is currently being conducted in Singapore in collaboration with KK Women’s and Children’s Hospital, Singapore and Singapore Cord Blood Bank.

CANULEX™ has received CE MDD in September 2017.