Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
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ClinicalTrials.gov Identifier: NCT01257776 |
Recruitment Status :
Completed
First Posted : December 10, 2010
Last Update Posted : August 5, 2015
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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 or disease | Intervention/treatment | Phase |
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Critical Limb Ischemia (CLI) Diabetes | Drug: Autologous adipose derived mesenchymal stem cells | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | July 2015 |
Arm | Intervention/treatment |
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Active Comparator: Mesenchymal stem cells 0,5 million * weight (kg)
Group of low dose of Mesenchymal stem cells.
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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
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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
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257776
Spain | |
University Hospital Virgen Macarena | |
Seville, Spain, 41007 | |
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine) | |
Seville, Spain, 41092 |
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 |
Responsible Party: | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud |
ClinicalTrials.gov Identifier: | NCT01257776 |
Obsolete Identifiers: | NCT01079403 |
Other Study ID Numbers: |
CeTMAd/ICPD/2008 |
First Posted: | December 10, 2010 Key Record Dates |
Last Update Posted: | August 5, 2015 |
Last Verified: | November 2014 |
Critical Limb Ischemia (CLI) Diabetes Mesenchymal Stem Cells Regenerative Therapy |
Ischemia Pathologic Processes |