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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Iniciativa Andaluza en Terapias Avanzadas
Information provided by (Responsible Party):
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01257776
First received: December 9, 2010
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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)


Condition Intervention Phase
Critical Limb Ischemia (CLI)
Diabetes
Drug: Autologous adipose derived mesenchymal stem cells
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: Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients

Further study details as provided by Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ankle Brachial Index [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: No ]
  • University of Texas Classification at target limb [ Time Frame: 1 month, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: December 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mesenchymal stem cells 0,5 million * weight (kg)
Group of low dose of Mesenchymal stem cells.
Drug: Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery
Active Comparator: Mesenchymal stem cells 1 million * weight (kg)
Group of mid dose of mesenchymal stem cells
Drug: Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery
No Intervention: Controlled group
Controlled group with no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01257776

Locations
Spain
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, Spain, 41092
University Hospital Virgen Macarena
Seville, Spain, 41007
Sponsors and Collaborators
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
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
  More Information

No publications provided

Responsible Party: Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01257776     History of Changes
Obsolete Identifiers: NCT01079403
Other Study ID Numbers: CeTMAd/ICPD/2008
Study First Received: December 9, 2010
Last Updated: November 13, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud:
Critical Limb Ischemia (CLI)
Diabetes
Mesenchymal Stem Cells
Regenerative Therapy

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014