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

NCT00922389 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-06-17

No results posted yet for this study

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.

Conditions

  • Diabetic Foot
  • Critical Limb Ischemia
  • Leg Ulcers

Interventions

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

Sponsors & Collaborators

  • Beike Biotech India Pvt.ltd

    lead INDUSTRY

Principal Investigators

  • Dr. Anoop Misra, MD · Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, India

  • Dr.DAI . · Beike Biotech

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00922389 on ClinicalTrials.gov