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Applications
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It is increasingly
apparent that the supply of organs is limited and will not improve
with current medical practice. The company's technology will enable
creation of tissue banks that will provide a constant flow of
necessary organs.
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 Liver
Tissue
Pancreas
Tissue
Kidney
Tissue
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The liver is a large organ with
a tremendous reserve of tissue that allows the continued function
of the organ, despite a loss of up to 90% of the normal complement
of liver cells. Researchers have shown in animal models that liver
cell integration is possible when liver cells are injected into
the liver or into the spleen. In many cases, the spleen appears
to be the preferred site due to liver damage. Liver cells implanted
in the spleen perform normal liver functions.
The company intends to focus on two lines of products:
1. Functional organs - full transplantation of a liver in cases
such Cirrhosis and other chronic liver diseases.
2. Tissue implants for expression of specific proteins for treating
hemophilia and other protein deficiency diseases.
Implanting tissue that will mature and express desired proteins
is less complicated than developing functional organs such as
the Company intends to do in its kidney-tissue program. For this
reason, Tissera expects its liver tissue implants to be the Company’s
first application to reach the clinic and benefit patients.
Cirrhosis
Cirrhosis of
the liver is a common affliction. In the United States,
cirrhosis affects an estimated 1.5 million individuals and leads
to approximately 50,000
deaths, annually. In cirrhosis, liver tissue is progressively lost due
to accumulation of fibrous tissue and scarring, and liver function
is compromised due to the degenerative changes. The most common
causes of cirrhosis are viral hepatitis B and C infections and
alcoholic liver disease. In the initial stages of the disease,
the patient may experience jaundice and disorientation as liver
function decreases. As the disease progresses, the patient will
be hospitalized with increasing central nervous system effects.
The only effective therapy for advanced cirrhosis is liver transplantation.
However, the lack of donor livers, results in a waiting period
of over two years for the average patient.
Hemophilia
Hemophilia
is an inherited bleeding disorder caused by the absence of a vital
blood clotting protein, either factor VIII or factor IX. Both
conditions are characterized by episodes of prolonged bleeding,
especially into muscles, joints, or internal organs. Hemophilia
A (factor VIII deficiency) affects approximately one in 7,500
males; hemophilia B (factor IX deficiency) is less common, accounting
for only about 15-20% of cases of hemophilia. The total number
of individuals with hemophilia in the United States is estimated
to be about 25,000. The severity of bleeding in hemophilia is
directly related to the degree of factor deficiency. Current therapy
involves the replacement of missing clotting factors. Treatment
must be repeated as half of the clotting factor infused is removed
by the body every 24 hours. A few individuals with hemophilia
have received liver transplants and were completely cured of their
hemophilia symptoms.
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Tissera plans to begin experiments implanting human
and porcine embryonic kidney-precursor cells in large animal models.
These experiments are designed to demonstrate the ability to grow
functional kidneys from committed stem cells and to connect these
kidneys to the host’s urinary system.
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Pancreas Tissue
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Diabetes Treatment
Pancreas transplant is a preferred treatment for type I “insulin-dependent”
diabetes.
Type I diabetes is an autoimmune disease in which insulin-producing
pancreatic islet cells are destroyed. Insulin is essential
for maintaining glucose balance and regulating carbohydrate,
lipid, and protein metabolism. Type I diabetes patients must
inject insulin, maintain a careful diet and monitor their
activity. However, with a transplanted pancreas, the type
I diabetes sufferer no longer requires insulin injections,
can enjoy a less restrictive diet and will be able to enjoy
greater activity and independence.
Recent reports from the International Pancreas Transplant
Registry (IPTR) suggest that pancreas transplant is helpful
for the more common type II diabetes as well. However, while
diabetes becomes increasingly common, the shortage of available
donor organs has grown.
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Development
The development plan of Tissera’ pancreatic-precursor
stem cell therapy will closely parallel that of the liver-precursor
stem cell therapy. Tissera is currently conducting experiments
to identify pancreatic precursor stem cells in human and porcine
embryos to determine the earliest time when these cells commit
to the pancreatic lineage. These cells will then be implanted
in mice to determine how they integrate with host vasculature
and to examine immune response.
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Kidney Tissue
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Kidney disease is becoming increasingly
prevalent. At the end of 2000, about 11% of the U.S. adult
population, 19.2 million people, were suffering from chronic
kidney disease. In the year 2000, there were 96,192 new cases
of kidney failure (“end stage renal disease” or “ESRD”) reported
in the United States, increasing at a rate of about 5% annually.
The most common causes were diabetes
(43%) and hypertension
(26%). There were
378,862 patients receiving treatment for end-stage renal disease,
including 275,053 dialysis patients and 103,809 with a functioning
kidney transplant. Over 40% of kidney transplants use organs
donated from living donors, a procedure involving considerable
pain and risk.
Tissera's scientists succeeded to harvest committed
kidney precursor tissue from human and porcine embryos and
implant it in mice where it developed into a functional kidney,
producing urine and integrating with the vasculature of host
mice.
Based on its laboratory results, Tissera hopes
to be able to provide a treatment, enabling severe chronic
kidney disease or end-stage renal disease patients to grow
a new kidney from implanted human or porcine kidney-precursor
tissue. The kidney patient could then forego a transplant
and, once the new kidney has grown, could be removed from
dialysis. It will eliminate the need to wait for appropriate
donor tissue or the need for painful kidney donations from
family members. It is expected to lengthen and improve the
quality of life for the patient.
United States Renal Data System. 2002 Annual Data Report.
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Development
Tissera initiated experiments
implanting human and porcine embryonic kidney-precursor cells
in pigs and in monkeys. These experiments were designed to
demonstrate the ability to grow functional kidneys from committed
stem cells in large animals and to connect these kidneys to
the host’s urinary system.
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Created By
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2003 |
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