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Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01257776
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : August 5, 2015
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud )

Tracking Information
First Submitted Date  ICMJE December 9, 2010
First Posted Date  ICMJE December 10, 2010
Last Update Posted Date August 5, 2015
Study Start Date  ICMJE December 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
  • Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis) [ Time Frame: 6 months ]
    Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
  • Major adverse event (death, target limb amputation) [ Time Frame: 1 month, 6 months, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
  • Ankle Brachial Index [ Time Frame: 1 month, 6 months, 12 months ]
  • University of Texas Classification at target limb [ Time Frame: 1 month, 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
Official Title  ICMJE Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
Brief Summary

A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.

The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.

In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Limb Ischemia (CLI)
  • Diabetes
Intervention  ICMJE Drug: Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery
Study Arms  ICMJE
  • Active Comparator: Mesenchymal stem cells 0,5 million * weight (kg)
    Group of low dose of Mesenchymal stem cells.
    Intervention: Drug: Autologous adipose derived mesenchymal stem cells
  • Active Comparator: Mesenchymal stem cells 1 million * weight (kg)
    Group of mid dose of mesenchymal stem cells
    Intervention: Drug: Autologous adipose derived mesenchymal stem cells
  • No Intervention: Controlled group
    Controlled group with no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2010)
36
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes, type 1 or 2
  • Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
  • No options for target limb revascularization.

Exclusion Criteria:

  • Cancer antecedent in the last two years
  • Current limb infection or limb gangrene
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257776
Other Study ID Numbers  ICMJE CeTMAd/ICPD/2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andalusian Network for Design and Translation of Advanced Therapies ( Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud )
Study Sponsor  ICMJE Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborators  ICMJE Iniciativa Andaluza en Terapias Avanzadas
Investigators  ICMJE
Principal Investigator: Rafael J Ruiz-Salmeron, MD, PhD University Hospital Virgen Macarena. Seville.Spain
Principal Investigator: Antonio De la Cuesta, MD University Hospital Virgen Macarena. Seville.Spain
PRS Account Andalusian Network for Design and Translation of Advanced Therapies
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP