Wednesday, July 13, 2016

$10 Million California Stem Cell Award for Creation of a New 'Lifeline" for Kidney Disease Patients


A 2014 interview with Laura Niklason, whose firm, Humacyte, will receive a $10 million award from California. The interview was conducted at the Stem Cells Meeting on the Mesa in La Jolla, Ca.

Highlights
$10 million matched by Humacyte
Three clinical trial locations in California
Humacyte raised $150 million last year

The California stem cell agency is set to award nearly $10 million for a phase 3 clinical trial to produce a new type of "lifeline" for kidney disease patients undergoing hemodialysis.

The $10 million award to Humacyte, Inc., of Morrisville, N.C., will go for final testing and development of an artificial vein that is critical for kidney disease patients who need hemodialysis.

The $10 million will be matched by the privately held firm. The state funds can only be spent for work performed in California to test the vascular access device. Humacyte plans clinical trial sites in Sacramento, Long Beach and Irvine.  

Formal approval of the award is expected to come July 22  at a telephonic meeting of the $3 billion agency's board of directors.

The stem cell agency traditionally does not identify recipients of awards until its board formally ratifies the decisions of its reviewers, which it almost never overturns. The California Stem Cell Report determined the identity  of the recipient using public sources.

According to the National Institute of Diabetes and Digestive and Kidney Diseases,
"A vascular access is a hemodialysis patient’s lifeline. A vascular access makes life-saving hemodialysis treatments possible. Hemodialysis is a treatment for kidney failure that uses a machine to send the patient’s blood through a filter, called a dialyzer, outside the body. The access is a surgically created vein used to remove and return blood during hemodialysis."

The Humacyte device, photo Humacyte
A summary of the closed-door review of the application described the product as a "human acellular vessel" that "has the potential for less frequent clotting, abandonment and infection." The summary said current technology is "fraught with complications."

Humacyte was founded in 2004 and raised $150 million last year in venture capital, according to an article last month by Meghana Keshavan on the STAT online biomedical news service. 

In the piece, Keshaven described the process of growing the vessels. She said each has "its own little plastic sack, which serves as a sort of womb for the vessel as it grows. Each bag’s connected to a central bioreactor tank that pumps out all the nutrients it needs — a carefully crafted 'soup' of vitamins, amino acids, and chemicals called cytokines that feed cells directions about how they’re supposed to grow."

Keshaven continued,    
"The lab-grown blood vessels are currently being studied in hemodialysis, a procedure that uses implanted veins as a conduit to remove waste from the blood of patients with kidney failure. Last month, promising results from a 60-patient midstage trial of Humacyte’s product were published in The Lancet."
Humacyte currently is recruiting 350 patients and expects to have preliminary results by July of next year. In response to a question this morning, Jeffrey Lawson, chief medical officer of the firm, said, 
Shannon Dahl,
co-founder Humancyte
Juliana Blum,
co-founder Humacyte
"We currently are engaged on using at least 3 clinical sites in California that should start enrolling patients (Sacramento, Long Beach and Irvine). We also have a number of manufacturing support programs based in California."
Founders of the firm include  Laura Niklason, professor of biomedical engineering and Yale, and Shannon Dahl and Juliana Blum, vice president of the firm.
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1 comment:

  1. Anonymous2:26 PM

    Why is CIRM funding this?
    Where are the stem cells in this product?
    How does this award fit into the CIRM mission to "de-risk" stem cell therapies? Isn't there a need for be stem cells to be involved in order for them to be de-risked?

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