Navigation Links
Gene Therapy Shows Promise as Treatment for Diseased Limbs

New research suggests that gene therapy is a safe treatment method to explore in patients whose lower limbs are at risk for amputation because of poor// circulation caused by blocked blood vessels.

In a Phase I clinical trial, almost half the patients receiving gene therapy reported complete resolution of chronic pain one year after treatment and more than a quarter of patients with chronic wounds experienced complete healing of those ulcers in the same time frame. The results appear online and are scheduled for publication in the March 13 issue of the journal Circulation.

The researchers are the first to report on testing of the effects of the hypoxia-inducible factor-1 alpha (HIF-1a) gene as the basis of treatment for limbs damaged by compromised blood flow. Though the trial largely focused on the therapy’s safety, “the bottom line is that 34 patients improved to varying degrees with this treatment,” said Dr. Sanjay Rajagopalan, section director of vascular medicine at Ohio State University Medical Center and first author of the Circulation article.

The treatment is currently being tested in a major Phase II clinical trial in the United States and Europe.

“If this gene therapy approach were to prove safe and effective after exhaustive testing in Phase III studies, it would provide clinicians with an alternative approach to treating patients with serious blood flow problems in their lower limbs,” Rajagopalan said.

Physicians are seeking better options to treat what is called critical limb ischemia because the condition often results in amputation and is characterized by chronic wounds that resist healing. The compromised blood flow is caused by severe blockages of peripheral arteries, or peripheral arterial disease (PAD), which occurs when cholesterol or plaque builds up in the arteries outside the heart – typically in the legs or pelvis. The one-year mortality rate in patients with critical limb ischemia is between 25 percent and 45 percent, and the risk of death increases with amputation.

An estimated 3 percent of Americans younger than age 60 have some degree of PAD, although they may not be aware of it because the early symptoms are often subtle. The frequency of the disorder increases with age, with more than 20 percent of individuals older than age 70 suffering from some form of it.

The current standard of care for critical limb ischemia includes the use of stents or balloons or bypass grafting to improve blood flow for patients who can tolerate such procedures. For many, these treatments offer only short-term benefits.

HIF-1a is considered a “master switch” gene produced naturally in the body that triggers the growth of blood vessel cells in patients with critical limb ischemia. The study drug, Ad2/HIF-1a/VP16, is a genetically modified form of the gene, intended to boost its active properties. The scientists theorized that HIF-1a may normalize oxygen levels in the cells by increasing interactions among multiple cytokines and genes that contribute to cell growth and facilitate survival of tissue damaged by reduced blood flow.

“Previous attempts to test gene-based formulations for critical limb ischemia have been disappointing, and that could be because the formulations tested were all single modality approaches that simply did not have the ability to induce the coordinated series of events required to induce vessel growth,” said Rajagopalan, also associate director of vascular research for Ohio State’s Davis Heart and Lung Research Institute.

He and colleagues administered the therapy through injections into the damaged limbs. The researchers completed two studies – a randomized, double-blind, placebo-controlled study, as well as an extension study in which participants, including some who had been receiving placebo, received the active treatment. Patients enrolled at five U.S. centers had at least on e main artery with complete or nearly complete blockage and no other options to fix the vessels.

Though 21 of 38 patients completing the trials experienced adverse effects, all negative events were attributed to their illness and not the study treatment.

Because the study group was small, no effect was attributed to different doses of the therapy.

At one year, 14 of 32 patients experienced complete resolution of pain while at rest, and five of 18 patients reported complete healing of chronic wounds. Other benefits included an increase in the number and size of visible vessels in affected legs.

Repeat administration of the study treatment is not considered an option because the body typically generates an immune response to gene therapy.

Source-Newsise
SRM
'"/>




Related medicine news :

1. Cancer Doctors Okays Controversial Prostate Therapy
2. Consensus on "Combination Therapy" for Breast Cancer
3. Gene Therapy shows promise in treating Hemophilia
4. "Make AIDS Therapy affordable" - Physicians demand
5. Hormone replacement Therapy a headache
6. Simple Therapy
7. Therapy for stopping the spread of cancer cells
8. Gene Therapy Destroys Pancreatic Cancer Cells
9. Letrozole Beats Tamoxifen in Breast Cancer Therapy
10. Garlic Supplements Impede HIV Therapy
11. Gene Therapy For Cystic Fibrosis
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/24/2016)... ... 24, 2016 , ... Those who have experienced traumatic events may suffer from ... avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid this ... coping following a traumatic event. , Trauma sufferers tend to feel a range of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... is proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon ... beautiful women in the world, and the most handsome men, look naturally attractive. ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... June 26, 2016 Story ... operating models within the health care industry is causing ... efficiency , Deloitte offers a suite of solutions ... issues impacting efficient cost optimization: labor resource analysis, revenue ... services facilitate better outcomes and better economics ...
(Date:6/24/2016)... 24, 2016 ... the addition of the " Global Markets for ... This report focuses on ... updated review, including its applications in various applications. The ... which includes three main industries: pharmaceutical and biotechnology, food ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
Breaking Medicine Technology: