Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Beike Biotech India Pvt.ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Beike Biotech India Pvt.ltd
ClinicalTrials.gov Identifier:
NCT00922389
First received: June 16, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Foot
Critical Limb Ischemia
Leg Ulcers
Procedure: will receive G-CSF and peripheral blood derived mononuclear cells
Drug: G-CSF
Drug: Standard Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Beike Biotech India Pvt.ltd:

Primary Outcome Measures:
  • Adverse events and laboratory parameters [ Time Frame: 12 Months after the theraphy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Trans Cutaneous partial pressure of Oxygen: TCpO2 [ Time Frame: 12 Months post thraphy ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-CSF + Stem cells 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.
No stem cell group Drug: G-CSF
5 micrograms/kg/day for 4 days by subcutaneous route
Active Comparator: Standerd theraphy
Any therapy for diabetic foot CLI which is routinely practiced and accepted in India
Drug: Standard Therapy
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922389

Contacts
Contact: Dr.Kumar Ramsamudara 0091 11 29552056 drkumar@ensindia.com
Contact: Dr.Prateek Gupta 0091 11 29552056 drprateek@ensindia.com

Locations
India
Fortis FLT.LT.Rajan Dhall Hospital Not yet recruiting
New Delhi, Delhi, India, 110 070
Principal Investigator: Dr.Anoop Misra, MD         
Sponsors and Collaborators
Beike Biotech India Pvt.ltd
Investigators
Principal Investigator: Dr. Anoop Misra, MD Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, India
Study Director: Dr.DAI . Beike Biotech
  More Information

No publications provided

Responsible Party: Director, Beike Biotech India Pvt.ltd
ClinicalTrials.gov Identifier: NCT00922389     History of Changes
Other Study ID Numbers: CNS-P0-V1
Study First Received: June 16, 2009
Last Updated: June 16, 2009
Health Authority: India: Indian Council of Medical Research

Keywords provided by Beike Biotech India Pvt.ltd:
Diabetes Complications
Lower limb ischemia
Adult stem cells
peripheral blood stem cells

Additional relevant MeSH terms:
Diabetic Foot
Ischemia
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Ulcer
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014