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

Primary Purpose

Diabetic Foot, Critical Limb Ischemia, Leg Ulcers

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
will receive G-CSF and peripheral blood derived mononuclear cells
G-CSF
Standard Therapy
Sponsored by
Beike Biotech India Pvt.ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetes Complications, Lower limb ischemia, Adult stem cells, peripheral blood stem cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fortis FLT.LT.Rajan Dhall Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

G-CSF + Stem cells

No stem cell group

Standerd theraphy

Arm Description

Any therapy for diabetic foot CLI which is routinely practiced and accepted in India

Outcomes

Primary Outcome Measures

Adverse events and laboratory parameters

Secondary Outcome Measures

Trans Cutaneous partial pressure of Oxygen: TCpO2

Full Information

First Posted
June 16, 2009
Last Updated
June 16, 2009
Sponsor
Beike Biotech India Pvt.ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00922389
Brief Title
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Beike Biotech India Pvt.ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
Keywords
Diabetes Complications, Lower limb ischemia, Adult stem cells, peripheral blood stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-CSF + Stem cells
Arm Type
Experimental
Arm Title
No stem cell group
Arm Type
Other
Arm Title
Standerd theraphy
Arm Type
Active Comparator
Arm Description
Any therapy for diabetic foot CLI which is routinely practiced and accepted in India
Intervention Type
Procedure
Intervention Name(s)
will receive G-CSF and peripheral blood derived mononuclear cells
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
G-CSF
Intervention Description
5 micrograms/kg/day for 4 days by subcutaneous route
Intervention Type
Drug
Intervention Name(s)
Standard Therapy
Intervention Description
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
Primary Outcome Measure Information:
Title
Adverse events and laboratory parameters
Time Frame
12 Months after the theraphy
Secondary Outcome Measure Information:
Title
Trans Cutaneous partial pressure of Oxygen: TCpO2
Time Frame
12 Months post thraphy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.Kumar Ramsamudara
Phone
0091 11 29552056
Email
drkumar@ensindia.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.Prateek Gupta
Phone
0091 11 29552056
Email
drprateek@ensindia.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Anoop Misra, MD
Organizational Affiliation
Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr.DAI .
Organizational Affiliation
Beike Biotech
Official's Role
Study Director
Facility Information:
Facility Name
Fortis FLT.LT.Rajan Dhall Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 070
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr.Anoop Misra, MD

12. IPD Sharing Statement

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

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