Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia

NCT04746599 | Unknown

• 1 other identifier: 1130
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  Primary endpoint is pain change or complete disappearance, according to Numeric Rating Scale (NRS) ranging from 0 (no pain) ad 10 (maximum amount of pain), ad TcPO2 improvement. The investigators will consider significative a pain change below NRS\<4 and a improvement in TcPO2 (\> 40 mmHg in patients with rest pain and no ischaemic lesions or \> 60 mmHg in patients with rest pain and ischaemic lesions) among at least 70% (14) of the patients enrolled in the study.

  7 days

Secondary Outcomes (1)

• Limb salvage

  30 days

Study Arms (1)

Patients with critic limb ischemia

EXPERIMENTAL

Patient enrolled from emergency room or outpatient population undergo pre-operatory tests including blood test, thoracic radiography, electrocardiogram, cardiologic visit, TcPO2 measurement and Doppler ultrasonography. During surgery the terminal branches of the patient's leg arteries are mapped and under local anesthesia multiple injections (1 mL each) of the adipose tissue formulation are inoculated 1 cm above the end of the terminal branch of the peroneal, anterior, and posterior tibial arteries. Furthermore, a total amount of 0.5-1 ml of the autologous adipose tissue-derived cell (ATDC) fraction is injected 1 cm near to ischaemic lesions. After the surgical procedure, the patient will be followed for 6 months, during which he will undergo outpatient visits at 7 and 21 days; then at 1, 3 and 6 months. At each visit, the patient will be assessed for the amount of pain, the transcutaneous oximetry value, measurement of the ABI index, arterial ultrasound Doppler lower limbs.

Procedure: Autologous Fat Grafting

Interventions

Autologous Fat Grafting PROCEDURE

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.

Also known as: adipose tissue transplantation

Patients with critic limb ischemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano

Milan, 20121, Italy

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Diabetic Foot; Scleroderma, Systemic; Thromboangiitis Obliterans

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Connective Tissue Diseases; Vasculitis

Study Officials

• Santi Trimarchi, Prof

  Fondazione IRCCS Cà Granda Ospedale Maggiore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Romagnoli, MD

CONTACT

+390255035492; silvia.romagnoli@policlinico.mi.it

Alberto Settembrini, MD

CONTACT

+390255035492; albertomaria.settembrini@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 10, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)