A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
Sponsor:
Beike Biotech
Hospital:
Beike Biotech
Location:
Fortis FLT.LT.Rajan Dhall Hospital
New Delhi, Delhi, India, 110 070
Country:
India One of the most devastating complications of diabetes is peripheral arterial disease (PAD) including critical limb ischemia (CLI), which canresult in limb loss. Epidemiological evidence confirms an association between diabetes and increased prevalence of peripheral arterial disease (PAD). The prevalence of peripheral vascular disease in the Indian diabetic population is 13%.
This therapy provides a targeted approach, i.e. by improving blood perfusion in the ischemic area of the lower limb by inducing neovascularization, which would be further evaluated by measuring the change in transcutaneous partial pressure of oxygen (TCpO2), NMR angiography of local vessels, ulcer healing, pain relief, limb salvage, ABI index and so on.
The specific design of the trial lets us differentially study the effect of stem cell on diabetic foot CLI as compared to G-CSF (granulocyte colony stimulating factor) in (one control group) and standard therapy (in another control group), this study would also evaluate the effect of stem cell dose.
Extracting stem cells from this method is far easier to perform as compared to extracting from bone marrow and is less painful for the patient as well.
The yield of mononuclear stem cell from peripheral blood is much higher as compared to bone marrow and role of CD34+ cells in limb ischemia is not yet established in humans, therefore this study would evaluate the dynamics of different types of mononuclear cells and its correlation with the therapeutic effect.
This clinical trial highlights the safety of using G-CSF in diabetic CLI by having a separate control group in which volunteers would be given only G-CSF through subcutaneous route, also this would tell about the therapeutic effect if any attributable to it.
Eligible Ages for Trial:
18 - 65
Eligible Genders for Trial:
Both
Illness:
Diabetes Inclusion Criteria:
- Diabetic patients with controlled blood sugar levels
- Subject has an Ankle-brachial index < 0.6
- Subjects with unilateral or bilateral diabetic critical limb ischemia (reduced TCpO2 (<30-45 mm Hg)) who are:
- TCpO2 < 30-45 mm Hg measured at the calf muscle
- Non reconstructable PAD as assessed by a qualified vascular surgeon on case to case basis depending upon results of angiography and clinical judgment.
- Lower extremity Ulcers of Grade II of Wagner's classification
- Subjects not likely to be benefited with prostaglandin E1
- 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 no stem cell treatment within the past 6 months o Subject is competent to provide informed consent and follow study procedures and instructions
- Subject has had previous conservative treatment which resulted in little or no improvement
Exclusion Criteria:
- All the subject below age 18 years and above 65 years.
- Any past or present malignancy
- 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
- Coronary angioplasty within the past 1 year
- Susceptibility to severe allergic reactions or a history of severe allergic reactions
- Recent occurrence (within 3 months) of myocardial infarction or brain infarction
- 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
- A positive pregnancy test in female subjects
- Lactating female with a breastfeeding child
- A presence of any other significant medical risk or a suspicion of future non-compliance
July 1, 2009 - January 1, 2011
Trial Status:
Recruiting Contact:
Dr.Kumar Ramsamudara 0091 11 29552056 drkumar@ensindia.com; Dr.Prateek Gupta 0091 11 29552056 drprateek@ensindia.com
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