Nanofat Grafting as a Method of Treating Critical Limb Ischemia

Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357936
• Other study ID #: CNMT002
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: February 20, 2025

Study information

• Verified date: April 2024
• Source: Center of New Medical Technologies
• Contact: Andrey V Ponomarenko, MD
• Phone: +79628316017
• Email: ponomarenko_av[@]cnmt.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 20, 2025
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Ischemia
• Limb Ischemia

Intervention

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
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.

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibirsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of pain absence in experimental group		12 months
Secondary	Number of any intraoperative complications		12 months
Secondary	Number of any inhospital complications		12 months
Secondary	Number of saved limbs		12 months
Secondary	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