A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
NCT ID: NCT00922389
Last Updated: 2009-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2009-07-31
2011-01-31
Brief Summary
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Detailed Description
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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 etc.
The specific design of the trial enables us to 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 more easy 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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G-CSF + Stem cells
will receive G-CSF and peripheral blood derived mononuclear cells
Multiple intra muscular implantation of mononuclear stem cells derived from peripheral blood after G-CSF (granulocyte colony-stimulating factor)mobilization in either of two individual dose ranges which would be given to equal number of subjects.
No stem cell group
G-CSF
5 micrograms/kg/day for 4 days by subcutaneous route
Standerd theraphy
Any therapy for diabetic foot CLI which is routinely practiced and accepted in India
Standard Therapy
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
Interventions
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will receive G-CSF and peripheral blood derived mononuclear cells
Multiple intra muscular implantation of mononuclear stem cells derived from peripheral blood after G-CSF (granulocyte colony-stimulating factor)mobilization in either of two individual dose ranges which would be given to equal number of subjects.
G-CSF
5 micrograms/kg/day for 4 days by subcutaneous route
Standard Therapy
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Beike Biotech India Pvt.ltd
INDUSTRY
Responsible Party
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Beike Biotech India Pvt.ltd
Principal Investigators
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Dr. Anoop Misra, MD
Role: PRINCIPAL_INVESTIGATOR
Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, India
Dr.DAI .
Role: STUDY_DIRECTOR
Beike Biotech
Locations
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Fortis FLT.LT.Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Other Identifiers
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CNS-P0-V1
Identifier Type: -
Identifier Source: org_study_id
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