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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Fundación Pública Andaluza Progreso y Salud.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01257776
First received: December 9, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

Critical limb ischaemia in diabetic patients is associated with high rates of morbidity and mortality. Sub-optimal responses to the available medical and surgical treatments are common in these patients, who also demonstrate limited vascular homeostasis. Neovasculogenesis induced by stem cell therapy could be a useful approach for these patients.

This is a randomized, open, controlled and multicentric study aimed to assess the safety and efficacy of intra-arterial administration of autologous adipose derived mesenchymal stem cells, in diabetic patients with critical limb ischemia of at least one limb and absence of any revascularization option.

36 patients would be included and randomized into four groups of 9 patients, depending on the mesenchymal stem cells concentration to be administered: 0,5 million cells/kg; 1 million cells/kg; 2 million cells/kg; and controlled group.

Efficacy primary endpoint is the angiographic demonstration of neovasculogenesis at 6 months follow up.


Condition Intervention Phase
Critical Limb Ischemia
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: Phase I-II Study of the Use of Human Adipose Derived Mesenchymal Stem Cells as Regenerative Therapy in Diabetic Patients With Critical Limb Ischemia

Further study details as provided by 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 ]

Estimated Enrollment: 36
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (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
Active Comparator: Mesenchymal stem cells 2 million * weight (kg)
Group of high 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

Contacts
Contact: Inmaculada C Perez-Camacho, MD, PhD +34955693440 ipercam06@gmail.com
Contact: Rafael J Ruiz-Salmerón, MD, PhD +34955693440 rjruizsalmeron@yahoo.es

Locations
Spain
University Hospital Virgen Macarena Recruiting
Seville, Spain, 41007
Contact: Inmaculada C Perez-Camacho, MD,PhD    +34955693440    ipercam06@gmail.com   
Sub-Investigator: Francisco Marcos, MD, Phd         
Sub-Investigator: Daniela De-Araujo, MD         
Sub-Investigator: Cesar Carrascosa, MD         
Sub-Investigator: Inmaculada C Perez-Camacho, MD, PhD         
Sub-Investigator: Miguel A Rico, MD         
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine) Recruiting
Seville, Spain, 41092
Contact: Inmaculada C Perez-Castejon, MD, PhD    +34955693440    ipercam06@gmail.com   
Contact: Abdelkrim Hmadcha, MD, PhD    +34955693440    Karim.Hmadcha@cabimer.es   
Sub-Investigator: Abdelkrim Hmadcha, MD, PhD         
Sub-Investigator: Itziar Ochotorena, MD, PhD         
Sub-Investigator: Bernat Soria, MD, PhD         
Sub-Investigator: Natividad Cuende, MD, PhD         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
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: Fundacion Progreso y Salud, Regional Andalusian Health Ministry
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: December 9, 2010
Health Authority: Spain: Spanish Medicine and Health-Care Products Agency. Ministry of Health

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Critical Limb Ischemia
Diabetes
Mesenchymal Stem Cells
Regenerative Therapy

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014