By Don C. Reed

Imagine being told that, to save your life, one of your legs must be cut off: amputated.

One possible cause of this nightmare is Critical Limb Ischemia (CLI), hardening of the arteries.

CLI is an all too common threat, especially with the aging of our society, and increasing numbers of diabetics.

“…Critical Limb Ischemia…may be present in as many as… two million Americans… it (may) result in amputation due to wounds that refuse to heal….”

Right now, surgery is our main defense. Angioplasty (balloons pushed into the arteries) may nudge aside the blockage in the “hardened” arteries. The blockage may be cut out with tiny knives, or frozen with helium. Little tubes called stents may be used to tunnel around the blockage.

But nearly half of such operations are unsuccessful.

Amputation may still be required — — and even that may not save the patient.

Could there be a stem cell weapon? Spain and California hope to find out.

With funding from CIRM, Dr. John Laird and Dr. Jan Nolta of the University of California at Davis Started a collaboration with Immaculada Herrador of the Hospital Universitario Reina Sofia in Spain. Although Dr. Laird recently retired, his team at the UC Davis Stem Cell Program is carrying on the research.

Dr. Jan Nolta is working to lessen or eliminate the need for amputations

How will they fight this terrifying condition?

With the help of a growth factor (VEGF, Vascular Endothelial Growth Factor) the body may be able to grow new arteries.

VEGF alone will not do the job; it may not go where it is needed.

But what if we had a microscopic “emergency vehicle”, to seek out the problem?

Mesenchymal stem cells (MSCs) can do that. Put into the body, MSCs travel to the trouble: the blockages in arteries and veins.

Add growth factor (VEGF) to the mesenchymal stem cell (MSC) and you have MSC/VEGF — the “paramedic van”, self-directing and full of good medicine!

As the scientists put it, in their progress report:

“Mesenchymal stem cells…are remarkably effective delivery vehicles, moving robustly through the tissue, infusing therapeutic molecules into damaged cells.”

Could it work?

“…Injections of MSC…have rapidly restored blood flow to the limbs of rodents who had zero circulation in one leg.

“We propose to use these MSCs as “nature’s own paramedic system”, arming them with VEGF to enhance…blood vessel growth.”

Scientists from California have visited the lab in Spain, and vice-versa, making sure the joint effort will be the same, when the human trials begin. The only difference will be how the MSC/VEGF will be administered: Spain is using an injection into the blood; UC Davis will give the shot into the muscle.

Multiple safety and efficacy experiments have been carried out, with each side bearing its own costs. If all goes well, the scientists intend to complete pre-clinical studies, move toward (FDA) regulatory approval, and initiate the clinical trials.

At the close of the 3rd year of their grant: “We have successfully engineered human MSCs to produce (high levels of) VEGF… and received…approval to proceed to the FDA… for the proposed stem cell gene therapy trial…”

These are the battles CIRM scientists fight, to save lives and prevent suffering.

But science moves in waves, forward and back, learning both from what works and what does not.

Progress was made through the CIRM funding.

Dr. Nolta continues the effort; only science will tell if her and her co-workers’ approach is successful.

Also, as Dr. Nolta put it: “None of this would have happened without CIRM. (CIRM is the California Institute for Regenerative Medicine, our state stem cell program, begun by Proposition 71.)“Thanks in large part to Prop 71, stem cell therapies are changing the way medicine is done…”

“In the future, when the mysteries of stem cell therapies are more fully understood, patients may not have to endure such…barbaric surgical techniques as limb amputation.” — Jan Nolta, personal communication.

On November 3rd, VOTE YES! on Prop 14, the California Stem Cell Research, Treatments and Cures Initiative of 2020.

The struggle must go on.

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