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SituGen
[edit]
SituGen is the commercial name of a disposable device and kit for cord blood stem cells collection, optimizing extraction of the umbilical cord system's blood. The SituGen method answers a clinical need for harvesting sufficient amounts of cord blood stem cells (CBSC), limited by current harvesting techniques. The volume of CBSC collected by the SituGen device and method allows for over 80% increase in the number of cells collected, enabling transplantation into adults, which are the main target for stem cell based therapies.
The device has completed the final clinical trials in Israel and will start its commercialization in Israel during July 2009. USA clinical trials are expected to commence during Q3 of 2009. SituGen is expected to be available for international marketing during Q3 of 2009.
Clinical need
[edit]The umbilical cord has been proven to be a vital source of stem cells used to treat life-threatening illnesses such as leukemia, cerebral palsy and brain injury. However, current harvesting methods used by cord blood banks worldwide are restricted by the fact that they can only harvest enough blood to treat a human averagely weighing 35 kg. (78 pounds), limiting their use mainly to pediatric applications. Transplants performed in adults have required the use of more than one stem cell dose, raising the issues of locating appropriate donations and meeting double and triple costs.
Current methods for extracting cord blood involve inserting a wide needle into the umbilical cord vain, keeping the placenta higher than the cord so blood is extracted by gravitation. Blood flows into a bag or a syringe while taking close care not to contaminate it with the mother's blood or external bacteria. Although some skilled collectors are able to extract more blood, the current method has produced around 72 milliliter blood out of 166 ml (average) generally present in the cord. The limited volume of blood collected from the umbilical cord substantially limits the ability to fully exploit its potential. Currently, the average volume of blood collected restricts the therapeutic use of CBSC to patients weighing an average of only 35kg (77 lbs), which eliminates the majority of adult patients.
The device
[edit]The SituGen device is made mainly of polypropylene and latex, comprising 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 chamber which can be removed when full, emptied and then refilled. The SituGen device is fully disinfected according to the requirements for all blood collection devices, needle-free and easy to use, not relying on the qualification or talent of the collector.
Comparison between methods
[edit]| Traditional method | SituGen |
|---|---|
| Passive Method 16G 1/2 mm diameter needle inserted into a 4mm vein causes a bottle-neck | Open collection in a needle free complete, fully sterile, hermetically Closed environment |
| Average of 72 mL - 8.3 x 10^8 TNC which is less than half the blood in the Placenta | Average of 118 mL - 15.1 x 10^8 TNC81 % more than of bags 73% of the after birth residual blood in the Placenta |
| Maternal Cells presence in up to 15% of the samples | Maternal Cells presence in 0% of the samples |
| Serves only patients weighing up to 35 kg (77 lbs) in Average | Serves patients weighing 64 Kg (141 lbs) in average |
| Mainly children | Children & adults |
| The Blood Donor Bag is one component in the Collection Kit | The SituGen is a comprehensive, all-inclusive Collection Kit. A sterile blister including peripheral assisting items for successful collection |
Situgen - scientific advisory board
[edit]Prof. Arnon Nagler - world renowned expert in stem cell transplants and umbilical cord blood. Prof. Nagler serves as the head of the Sheba Medical Center bone marrow transplantation department and the Public Cord Blood Bank as well as the Head of the Hematology Array. A member of NetCord, world network of public CB banks. Prof. Alexander Batler, head of cardiology at the Clalit health fund Prof. Eliezer Rachmilewitz, hematologist. Mr. Miki Shacham, LifBank & SituGen CEO and the inventor of the SituGen. During clinical tests the scientist discovered the problem concerning cord blood harvesting lays with what happens to the blood a few minutes after birth: the blood thickens or coagulates inside the cord making current collection methods used world-wide not sufficient enough.
Supporting investments and further research and development
[edit]SituGen is supported by Israel's OCS and the Rad BioMed Incubator, a subsidiary of Rad group. The company has initiated further research and development programs - the cord blood coagulation aspects in the placenta-umbilicus system. The choice of focusing SituGen's activities on cord blood stem cell collection derives from the advancements in stem cell research and the use of cord blood stem cells as an available, non-controversial, cost effective resource. Cord blood stem cells are used for transplants, tissue engineering, nuclear transfer and growing lab-made cells.
Intellectual property
[edit]The SituGen is a breakthrough technology and device entering an expecting and established market. IP based on several different patents were placed in Israel & the majority of the world's nations, covering the market active in cord blood applications and collections.
References
[edit]Gali Weinreb "Stem cell bank Biocord raises $2m", Globes online 2006-02-26 Retrieved 2009-06-24
Batya Feldman "Placenta blood co SituGen raises $1m", Israel Venture Capital research center 2006-10-19 Retrieved 2009-06-24
Tania Hershman "Israeli device lengthens the stem cell cord that save lives", Israel 21c 2006-02-26 Retrieved 2009-06-24
Sally Robbins "New Developments in Umbilical Cord Blood Technologies; Consolidation of U.S. Family Banks" life sciences world 2009-02-28 Retrieved 2009-06-24