Nanofat Grafting as a Method of Treating Critical Limb Ischemia

Nanofat Grafting as a Method of Treating Critical Limb Ischemia - Pilot, Prospective Randomised Blinded Trial

This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.

The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.

The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.

Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments.

Study Overview

• Status: Not yet recruiting
• Conditions: Limb Ischemia
• Intervention / Treatment: Procedure: nano-fat grafting in chronic limb ischaemia; Procedure: sham comparator

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrey V Ponomarenko, MD; Phone Number: +79628316017; Email: ponomarenko_av@cnmt.ru
• Study Contact Backup: Name: Pokushalov A Evgeny, Proff; Phone Number: 79133825952; Email: e.pokushalov@gmail.com

Study Locations

• Russian Federation
  • Novosibirsk Region
    • Novosibirsk, Novosibirsk Region, Russian Federation, 630090
      • Center of New Medical Technologies
      • Contact: Andrey V Ponomarenko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with occlusive lesions of the femoral-popliteal-tibial segment.
• Chronic ischemia of the lower limbs of III-IV degree according to Fontaine and categories 5-6 according to Rutherford.
• Signed informed consent for participation in the clinical trial.

Exclusion Criteria:

• Absence of indications for surgical intervention on the femoral-popliteal-tibial segment.
• Patients refusing to participate in the clinical trial.
• Chronic heart failure of III-IV NYHA functional class.
• Chronic decompensated "pulmonary" heart.
• Severe liver or kidney failure (bilirubin >35 mmol/L, glomerular filtration rate <60 ml/min).
• Polivalent drug allergy.
• Malignant oncological diseases in the terminal stage with a life expectancy of less than 6 months.
• Acute cerebrovascular accident.
• Decompensated diseases of the endocrine organs (for diabetes, glycemia level more than 10 mmol/L).
• Pregnancy and lactation period.
• Inability to undergo examinations at control points.
• Refusal to sign informed consent for participation in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nano fat grafting group	Procedure: nano-fat grafting in chronic limb ischaemia; The nano fat grafting procedure in the clinical trial involves the collection of adipose tissue under tumescent anesthesia, which is a technique to swell and firm the targeted area, through a separate puncture in the anterior abdominal wall. Following the collection, the adipose tissue undergoes a process of cannulation to prepare the nano fat. This prepared material is then injected into the tissues of the foot and leg using standard intramuscular injection needles. The injections are performed in various directions to ensure proper distribution of the nano fat. This method does not require additional drug therapy. It leverages the natural growth factors and stem cells present in adipose tissue, aiming to improve blood flow and tissue regeneration in limbs affected by critical ischemia. The unique aspect of this treatment is its focus on using autologous materials, minimizing the risk of rejection and side effects associated with foreign substances.
Sham Comparator: standard therapy group	Procedure: sham comparator; For the clinical trial, a sham procedure would be designed to mimic the nano fat grafting without providing the actual therapeutic intervention. This involve the patient undergoing a similar process with tumescent anesthesia and making a puncture on the anterior abdominal wall. However, instead of harvesting adipose tissue and preparing nano fat, a placebo solution (such as saline) would be injected using the same intramuscular injection technique. The aim of this sham comparator is to assess the psychological and physiological effects of the nano fat grafting procedure itself, by eliminating the potential therapeutic benefits of the nano fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of pain absence in experimental group	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of any intraoperative complications		12 months
Number of any inhospital complications		12 months
Number of saved limbs		12 months
Percent change in visual analog pain score (VAS) change	The Visual Analogue Scale (VAS) is a straightforward, tool for measuring pain intensity or other subjective experiences that are difficult to quantify, such as fatigue or nausea. It consists of a straight line, usually 10 centimeters (100 millimeters) long, anchored by two descriptors defining the extremes of the experience being measured (e.g., "no pain" on one end and "worst imaginable pain" on the other for pain measurement).. The result is typically recorded in millimeters, with scores ranging from 0 to 100, where 0 represents one extreme (e.g., no pain) and 100 represents the other (e.g., worst imaginable pain).	12 months

Collaborators and Investigators

• Sponsor: Center of New Medical Technologies

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): February 20, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Critical limb ischemia; Autologous stem cells; Nano fat grafting; Limb preservation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: CNMT002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No