Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia (NCT04746599) | Clinical Trial Compass
UnknownNot Applicable
Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia
Italy20 participantsStarted 2021-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain reduction
Timeframe: 7 days
Trial details
NCT IDNCT04746599
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico