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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000290-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Hospital Universitario La Paz | OTHER |
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It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate.
Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner
The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse events will be collected during the same time monitoring the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy.
Secondary endpoints: As part of the evaluation of the quality of life of patients and clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous mesenchymal stem cells | Experimental | Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular injection of a suspension of adult mesenchymal stem cells derived | Other | Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of inject mesenchymal stem cells in MMII | It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patients after treatment | We analyze the quality of life of patients by SF-12 test | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of patients after treatment | Clinical evaluation of patients after treatment with magnetic resonance angiography, tissue oximetry records and ankle-brachial index. | One year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Riera del Moral, Doctor | Instituto de Investigación Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
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