WALQ team for saving limbs and keeping Californians on their feet

Funding Type: 
Disease Team Research I
Grant Number: 
DR1-01453
Investigator: 
ICOC Funds Committed: 
$0
Public Abstract: 
The goal of the WALQ team is to develop and apply safe and effective stem cell therapies to save limbs from amputation due to disorders of the vasculature, skin, and bone that currently cannot be cured. The implementation of our planned therapies will significantly reduce the cost of healthcare in California. Critical Limb Ischemia (CLI) represents an unmet medical need without any curative therapies in its end stages. Even the best revascularization attempts using sophisticated catheters and stents have failed. CLI affects 2 million people in the US, with painful symptoms that often do not respond to therapy. Patients experience diminished quality of life, progress to immobility and need constant care. The final stage is often limb amputation, followed by death within 6 months. The rate of primary amputation at initial presentation is as high as 25%. Amputation rates in patients not suitable for revascularization are reported to be up to 30-50% after 1 year. Treatment costs are exorbitant and lives are significantly shortened by this disease. Chronic skin ulcers present another immense burden and challenge to patients, payers, and society. Venous stasis ulcers, which account for 80-90% of all leg ulcers, occur at a higher incidence in people over 60, a growing part of our society. These ulcers do not easily heal, need constant medical attention, put patients at risk for infections, and can immobilize the individual. They can lead to severe complications (necrosis and gangrene) leaving no alternative but amputation. The number of cases in the US surpasses 700,000 annually, with the cost for chronic patient care ranging from $20-30K per patient. It has also been estimated that in the U.S., nearly a billion dollars are spent annually treating venous ulcers. The current standard of care often does not improve wound healing. Osteoarthritis impacts the quality of life of more than 20 million Americans. Normal bone tissue is highly plastic and is constantly rebuilt to adapt to changing demands. It is vascularized with sufficient amounts of oxygen and nutrients provided through the bloodstream for new bone formation. Avascular necrosis of the bone (AVN) is a painful and debilitating disease resulting from loss of the blood supply, causing bones to weaken and collapse. This disease manifests itself in the load bearing joints, particularly the hip. Advanced stages are treated with total hip replacement, which has many drawbacks. Patients with sickle cell anemia can also develop avascular necrosis which may lead to complete disability at a very young age. The costs of care for the lifetime of the disabled person are high; along with the personal suffering due to the inability to move without pain. Our three clinical trials proposed to treat vascular, wound, and bone disease can be relatively rapidly and safely implemented to see a significant and measurable reduction in the costs of long-term care for these debilitating diseases, throughout California
Statement of Benefit to California: 
The goal of the WALQ team is to develop and apply safe and effective stem cell therapies to save limbs from amputation due to disorders of the vasculature, skin, and bone that currently cannot be cured. The implementation of our planned therapies will significantly reduce the cost of healthcare in California. Critical Limb Ischemia (CLI) represents a significant unmet medical need without any curative therapies in its end stages, after even the best revascularization attempts using sophisticated catheters and stents have failed. CLI affects 2 million people in the US, causes painful symptoms which often do not respond to therapy. Patients experience greatly diminished quality of life, progress to immobility and need constant care. The final stage, in many cases is limb amputation, often followed by death within 6 months. The rate of primary amputation at initial presentation is as high as 25%. Amputation rates in patients not suitable for revascularization are reported to be up to 30-50% after 1 year. Treatment costs are immense and lives are significantly shortened by this disease. Chronic skin ulcers present another immense burden and challenge to patients, payers, and society. Venous stasis ulcers, which account for 80-90% of all leg ulcers, occur at high incidence rates in people over 60 years of age, a largely growing part of our society. These ulcers do not heal easily, need constant medical attention, put patients at risk for infections, and often immobilize the individual. Over a period of time they can also cause severe complications (necrosis and gangrene) leaving no other alternative but amputation. The number of cases in the US surpasses 700,000 annually, with the cost for chronic patient care ranging from $20-30K per patient. It has also been estimated that in the U.S., nearly a billion dollars are spent annually treating venous ulcers. The current standard of care may improve outcome, but in many cases there is no improvement in healing. New therapies are desperately needed. Osteoarthritis severely compromises the quality of life of more than 20 million Americans. Normally, bone tissue is highly plastic and is constantly rebuilt to adapt to changing demands. Therefore, it is greatly vascularized to receive sufficient amounts of oxygen and nutrients through the bloodstream for new bone formation. Avascular necrosis of the bone (AVN) is a painful and debilitating disease resulting from loss of the blood supply to the bones, causing them to weaken and collapse. This disease manifests itself in highly load bearing joints, particularly the hip. Advanced stages are treated with total hip replacement, which has many drawbacks. Another group, patients with sickle cell anemia can also develop avascular necrosis which may lead to complete disability at a very young age. The costs of care, for the rest of the life of the disabled person are very high, let alone the suffering from not being able to move without pain. Our three clinical trial

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