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Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia

NCT04746599 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease - PAD
  • Ischemic Ulcer
  • Ischemic Feet
  • Diabetic Foot
  • Scleroderma, Systemic
  • Thrombo Angiitis Obliterans
  • Ischemic Leg

Interventions

PROCEDURE

Autologous Fat Grafting

The trochanteric area or the periumbilical abdominal region represents the donor sites. Following Coleman's technique and after the administration of modified Klein solution, a skin incision is performed in the selected area. Adipose tissue is harvested and after suture the area is managed with an elastic-compressive dressing, to be kept in place for 5 days to prevent hematoma formation. The adipose tissue is the centrifuged at 920 × g for 3 min in sterile conditions. Only the intermediate layer containing adipocytes and stromal vascular component will be then injected using a blunt cannula. The terminal branches of the patient's leg arteries are mapped to facilitate graft placement. Under local anesthesia multiple injections of the adipose tissue formulation are inoculated 1 cm above the end of the terminal branch of the peroneal, anterior, and posterior tibial arteries.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Santi Trimarchi, Prof · Fondazione IRCCS Cà Granda Ospedale Maggiore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04746599 on ClinicalTrials.gov