الفهرس 
Blood Vessels Structure and FunctionOnly 14 pages are availabe for public view
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Abstract
Peripheral arterial disease is a progressive illness, and the most severe manifestation is termed “critical limb ischemia” (CLI). It is estimated that approximately 5 million people world wide are suffering intermittent claudication (Criqui MH., et al.,2001). The vast majority of patients with intermittent claudication are typically managed conservatively with a walking program and cilostazol therapy(Criqui MH.,et al.,2001). Despite these therapies, most patients continue to have pain with ambulation, which affects their quality of life. The most severe manifestation of PAD is CLI, defined as rest pain and/or tissue loss. CLI develops in 500 to 1,000 individuals per million per year (Dormandy J.et al.1999). These patients experience chronic ischemic rest pain, ulcers, or gangrene in the lower limbs, and have a very poor prognosis. Many will undergo amputation, and their quality of life is described as being similar to that in patients with critical- or terminal-stage cancer.
Therapeutic angiogenesis is a novel strategy for the treatment of ischemic vascular disease. It uses angiogenic factors to increase blood perfusion in ischemic tissues through various mechanisms of action.
In this study, we explored the outcome measures available to report success rates after 6 months follow-up after stem cell therapy for inoperable lower limb disease. The six months follow up and in hospital outcome was a reflection of the clinical success. Symptomatic improvement of the patient’s symptoms considered the golden key for the success of stem cell therapy whereas reporting of six months follow up was based on symptoms improvement and imaging tests but the basic angiography was terminated due to invaluable data in our study and PROVASA study(nephropathy necessitating dialysis and no new arteries had been seen).
This study is a prospective study that will be conducted in San Matteo Hospital(Italy) on patients with peripheral arterial disease unfit for percutaneous transluminal angioplasty or bypass surgery.
Inclusion criteria:
All patients with severe peripheral occlusive arterial disease unfit for percutaneous transluminal angioplasty or bypass surgery will constitute the population of this study.
Methods of the study:
All patients included in this study from october 2008 to october 2009 in San Matteo hospital with previous criteria will be subjected to the following:
1. Full history taking , with special emphasis on:
• Age.
• Sex.
• Diabetes mellitus.
• Hypertension.
• Renal impairment.
• Smoking.
• The presence of coronary artery disease.
2. Complete general and local clinical examination with special emphasis on lower limb examination for color changes, ulcers, temperature and pulsations.
3. Electrocardiography.
4. These patients will be treated by injection of prepared stem cell by laboratory techniques as we will use a microcatheter to inject the solution of stem cell to severely diseased inoperable lower limb ischemia.
5. they will be treated also by medical treatment(walking program and drugs).
Based on the variation in the definitions of success reported in the studies evaluating daily practice, we assumed two main parameters of success: clinical and technical. Clinical success was defined as immediate no complication, while the technical success was defined as success to inject the stem cells solution via intra-arterial or intramuscular with no complications.
Six months follow up results:
90% of patients were alive six months after the stem cells injection. The major causes of death were: sudden cardiac death (3.33%), leg gangrene (3.33%), and other causes as massive cerebral hemorrage (3.33%).
The rest pain disappeared in more than 90% of the patients, 63% had increased walking distance for more than 50 meters and complete healing of ishamic leg ulcers had 59.3%. Amputation was prevented in 88.9% of patients.
The current study showed no difference between the two groups in clinical outcome with respect to death and limb salvage during follow up after 6 months, 3 patients died in stem cell group and 3 patients died in medical group, 90% of patients of both groups were alive 6 months after the treatment. The major causes of death were: sudden cardiac death (2 patients), leg gangrene (1 patient %), other causes as intestinal obstruction, strokes and sepsis (3 patients).
There was no difference between intaarterial(were done in 12 patients) and intramuscular injection of stem cell(were done in 15 patients) on the outcome of the patients during the follow up.there is no complication for both types of injection a part from intramuscular injection was painful.
Finally the present study did not address the question of whether intraarterial cell administration is superior to intramuscular injections. However experimental studies demonstrated that the administered BM-MNC needs to be repeted for at least twice to improve the clinical outcome by increasing the capillary and arteriolar vessel density.
We used the intraarterial more than intramuscular route based on the assumption that intraarterially applied cells will only home to tissue with preserved nutrient blood supply.