Diabetic FootPhase 1/2NCT00922389
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
A Phase 1/2 study testing will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF and Standard Therapy in people with Diabetic Foot and Critical Limb Ischemia, run by Beike Biotech India Pvt.ltd at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- What is being tested?
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF and Standard Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2009to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis FLT.LT.Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, 110 070
Dr.Anoop Misra, MD
About this study
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.
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.
Read the 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
- Being tested
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Keywords
- Diabetes Complications, Lower limb ischemia, Adult stem cells, peripheral blood stem cells
- Medical subject headings
- Diabetic Foot, Chronic Limb-Threatening Ischemia, Leg Ulcer, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
will receive G-CSF and peripheral blood derived mononuclear cellsProcedure or surgery
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-CSFDrug
5 micrograms/kg/day for 4 days by subcutaneous route
Standard TherapyDrug
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
| Study group | Role | What they receive |
|---|---|---|
| G-CSF + Stem cells | Experimental | Not described Receives: Procedure: will receive G-CSF and peripheral blood derived mononuclear cells |
| No stem cell group | Other | Not described Receives: Drug: G-CSF |
| Standerd theraphy | Active comparator | Any therapy for diabetic foot CLI which is routinely practiced and accepted in India Receives: Drug: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and laboratory parameters
Measured: 12 Months after the theraphy
Secondary outcomes (1)
Trans Cutaneous partial pressure of Oxygen: TCpO2
Measured: 12 Months post thraphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beike Biotech India Pvt.ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Anoop Misra, MD, Principal investigator, Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, IndiaDr.DAI ., Study director, Beike Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922389
- Sponsor's protocol ID
- CNS-P0-V1
- Status last verified
- Jun 2009
- First submitted
- 16 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00922389
- Acronym / sponsor ID
- CNS-P0-V1
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Keywords
- Diabetes Complications, Lower limb ischemia, Adult stem cells, peripheral blood stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beike Biotech India Pvt.ltdIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G-CSF + Stem cells | Experimental | Procedure: will receive G-CSF and peripheral blood derived mononuclear cells |
| No stem cell group | Other | Drug: G-CSF |
| Standerd theraphy | Active comparator | Drug: Standard TherapyAny therapy for diabetic foot CLI which is routinely practiced and accepted in India |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Lower extremity Ulcers of Grade II of Wagner's classification
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| will receive G-CSF and peripheral blood derived mononuclear cellsMultiple 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. | Procedure or surgery | G-CSF + Stem cells |
| G-CSF5 micrograms/kg/day for 4 days by subcutaneous route | Drug | No stem cell group |
| Standard TherapyAny thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc | Drug | Standerd theraphy |
Primary outcome
Adverse events and laboratory parameters
Time frame: 12 Months after the theraphy
1 secondary outcome
Trans Cutaneous partial pressure of Oxygen: TCpO2
Time frame: 12 Months post thraphy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Anoop Misra, MD principal investigator
Fortis FLT.LT.Rajan Dhall Hospital ,New Delhi, India
Dr.DAI . study director
Beike Biotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF and Standard Therapy in people with Diabetic Foot and Critical Limb Ischemia, run by Beike Biotech India Pvt.ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.Kumar Ramsamudara (0091 11 29552056, drkumar@ensindia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and laboratory parameters (time frame: 12 Months after the theraphy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.