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

• ClinicalTrials.gov Identifier: NCT01257776
• Recruitment Status: Completed
• First Posted: December 10, 2010
• Last Update Posted: August 5, 2015
• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• 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: December 9, 2010
• First Posted Date: December 10, 2010
• Last Update Posted Date: August 5, 2015
• Study Start Date: December 2010
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Critical Limb Ischemia (CLI)
• Diabetes

Intervention

Drug: Autologous adipose derived mesenchymal stem cells

Intra-arterial administration through a selective cannulation of target common femoral artery

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2014): 33
• Original Estimated Enrollment (submitted: December 9, 2010): 36
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01257776
• Other Study ID Numbers: CeTMAd/ICPD/2008
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborators: Iniciativa Andaluza en Terapias Avanzadas

Investigators

• 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