Product Overview
ViaCyte is an investigational product intended to broaden reproductive options for women through the cryopreservation and thawing of human unfertilized oocytes (eggs). The oocyte is a large cell with a high content of water, historically making it difficult to freeze. ViaCell’s proprietary technology to freeze and thaw oocytes uses a choline chloride-based media designed to protect the cells from damage during the freezing process.
In March 2007, ViaCell commenced a pivotal clinical trial to evaluate its ViaCyte media. The study is expected to be completed in 2009, and if the results are positive, ViaCell plans to file for FDA clearance of ViaCyte. Currently, there is no FDA-cleared product for egg freezing.
Clinical Overview
The open-label pivotal clinical trial is designed to determine the efficacy of ViaCyte media for the freezing and thawing of mature human oocytes. Participants in the study will undergo traditional IVF. After the eggs are retrieved, they will be frozen using ViaCyte and stored frozen for several weeks. The oocytes will be thawed following storage in liquid nitrogen and subsequently inseminated. Embryos will be transferred to the subject’s uterus using a non-surgical procedure.
Clinical Trials
Women seeking in vitro fertilization (IVF), diagnosed with male factor infertility between 21 – 35 years of age are eligible to enroll.
A complete description of the trial, entitled, Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology, is available online at www.clinicaltrials.gov.
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Please note, this is not a ViaCell study. This study is being conducted by the University of Florida.
Cord blood contains a large number of immune cells called regulatory T cells. These regulatory T cells may be helpful in diminishing autoimmunity. The need to re-establish tolerance in patients with established autoimmunity provides another potential mechanism for cord blood as a therapy for Type 1 diabetes.
In April 2005, the University of Florida commenced a clinical trial to transfuse autologous umbilical cord blood into children with Type 1 diabetes. The study is expected to be completed in 2009.
Clinical Overview
The University of Florida is conducting an open-label clinical trial in children recently diagnosed with Type 1 diabetes whose families banked their umbilical cord blood. The umbilical cord blood will be infused into the children in an attempt to re-establish immune tolerance and perhaps regenerate pancreatic islet insulin-producing beta cells and improve blood glucose control
Clinical Trial
Children greater than 1 year of age with Type 1 diabetes whose umbilical cord blood was stored with an AABB and/or FACT accredited cord blood bank are eligible to enroll. This trial is not currently using sibling cord blood.
A complete description of the trial, entitled, Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study, is available online at www.clinicaltrials.gov.
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