NCT00922389

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

A Randomized, Controlled, Parallel Design, Safety and Efficacy Study of Granulocyte Colony Stimulating Factor Mobilized Autologous Peripheral Blood Mononuclear Cell Therapy in Subjects With Diabetic Limb Ischemia.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Beike Biotech India Pvt.ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

One devastating complication of diabetes is peripheral arterial disease (PAD) including critical limb ischemia (CLI), which may result in limb loss. Epidemiological evidence confirms an association between diabetes and increased prevalence of peripheral arterial disease (PAD). The prevalence of peripheral vascular disease among 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 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

• Diabetic Foot
• Critical Limb Ischemia
• Leg Ulcers

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	G-CSF	5 micrograms/kg/day for 4 days by subcutaneous route
DRUG	Standard Therapy	Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2009-06-17
• Last updated: 2009-06-17

Locations

1 site across 1 country: India