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
Recruitment status was Recruiting
Sponsor:
Fundación Pública Andaluza Progreso y Salud
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
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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 |
Resource links provided by NLM:
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
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:
|
Diabetes Mellitus Ischemia Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013