A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia

• Status: Unknown status
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beike Biotech India Pvt.ltd
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Diabetic patients with controlled blood sugar levels

• Subject has an Ankle-brachial index < 0.6

• TCpO2 < 30-45 mm Hg measured at the calf muscle

• Subjects with unilateral or bilateral diabetic critical limb ischemia (reduced TCpO2 (<30-45 mm Hg)) who are:

• Non reconstructable PAD as assessed by a qualified vascular surgeon on case to case basis depending upon results of angiography and clinical judgment.

• Subjects not likely to be benefited with prostaglandin E1

• Lower extremity Ulcers of Grade II of Wagner's classification

• All subjects test negative for human immunodeficiency virus, hepatitis B virus, hepatitis C virus and treponema pallidum and their respective antibodies

• S Creatinine < 2.5 mg/dL

• All female participants in the study should be practicing a medically acceptable form of contraception (IUD, the pill etc.)

• Subject has had previous conservative treatment which resulted in little or no improvement

• Subject has had no stem cell treatment within the past 6 months o Subject is competent to provide informed consent and follow study procedures and instructions

Exclusion Criteria:

• All the subject below age 18 years and above 65 years.

• The presence of Ischemic ulcers with infectious symptoms anywhere on the lower extremity (Grade 3 and above of Wagner classification would be excluded from the study in the screening period)

• Diabetes mellitis with HbA1c > 8.5% or associated with proliferative retinopathy

• Any past or present malignancy

• Susceptibility to severe allergic reactions or a history of severe allergic reactions

• Recent occurrence (within 3 months) of myocardial infarction or brain infarction

• Coronary angioplasty within the past 1 year

• Atrial fibrillation or presence of mechanical mitral prosthetic valve

• Presence of uncontrolled systemic infection or its ongoing treatment

• Existing vital organ dysfunctions, including heart, lung or kidneys

• Coagulation disorders such as hemophilia, etc

• Use of any medication relevant to revascularization or perfusion

• Lactating female with a breastfeeding child

• A positive pregnancy test in female subjects

• A presence of any other significant medical risk or a suspicion of future non-compliance