Clinical Trials

 

Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia Non Suitable for Revascularization: The Adipose Tissue - Critical Limb Ischaemia (ADIPOCLI) Trial Protocol

Intervention Type: Procedure
Study Type: Interventional
Sponsors: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Participants: 20
Abstract
Critical Limb Ischaemia (CLI) is a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene for more than 2 weeks in one or both legs, attributable to objectively proven arterial occlusive disease.CLI is associated with a high risk of lower amputation, diminished quality of life and mortality. Revascularization by either bypass surgery or endovascular recanalization is considered the first-choice treatment in patients with CLI. Revascularization is not always possible because patients with CLI often have severe comorbidities or because it is not technically feasible. On the basis of their well-recognized regenerative and angiogenetic properties, cell therapy with autologous bone marrow-derived mesenchymal stem cells (BMMSCs) has been proposed and tested in different animal models and in some human pathological conditions characterized by peripheral ischemia and wound formation.
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Facilities
Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano - Recruiting
Milan, Italy
Contacts
Primary
Silvia Romagnoli, MD
silvia.romagnoli@policlinico.mi.it
+390255035492
Backup
Alberto Settembrini, MD
albertomaria.settembrini@gmail.com
+390255035492
Eligibilities
Sex: All
Minimum Age: 18
Healthy Volunteers: No
Inclusion Criteria:
- Age > 18
- Established diagnosis of CLI according to TransAtlantic InterSociety Consensus (TASC II) guidelines
- Ankle oxygen partial pressure < 40 mmHg with no ischaemic lesions or < 60 mmHg with ischaemic lesions
- Tibial injections site free from ulcers
- Absence of comorbidities responsible for life expectancy < 6 months
- Non suitability for surgery (comorbidities or angiographic results)
- Informed consent taken
Exclusion Criteria:
- Age < 18 years
- Inability of understanding and signing informed consent
- Tibial injections sites involved by ulcers
- Life expectancy < 6 months
- Unwillingness to attend follow up
- Any of the following: women who are or may be pregnant or women hoping to become pregnant; women who are breastfeeding; men whose partners hope to become pregnant during the treatment period

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