Suspended

Use of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries

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What is being tested

Autologous Fat Grafting

+ Primary Nerve Repair

Procedure
Who is being recruted

Nervous System Diseases+3

+ Neuromuscular Diseases

+ Peripheral Nervous System Diseases

From 16 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2021
See protocol details

Summary

Principal SponsorAssiut University
Study ContactAhmed S Sharaf, MsC
Last updated: January 28, 2026
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Study start date: January 1, 2021

Actual date on which the first participant was enrolled.

Traumatic injuries to peripheral nerves are a frequent finding after hand trauma. High morbidity after nerve injuries mainly affects the younger and working population, with consequent decrease in life quality and productivity . Even in direct nerve repair and microsurgical nerve coaptation, regeneration is often suboptimal with incomplete target reinnervation. Suboptimal outcome is attributed to axonal degeneration, fibrotic scar formation, and neuromas at the site of injury. The use of adipose tissue has become very popular in tissue engineering and reconstructive surgery in recent years. It is proposed as a "regenerative tool" for various tissues, including peripheral nerves, because it offers an effective and minimally invasive procedure for obtaining stem cells. Unprocessed fat grafting can provide a simple approach to improve peripheral nerve regeneration by means of neoangiogenesis \& inflammatory response modulation. Furthermore, it serves as a good protective barrier in peripheral nerve surgery, reducing fibrosis and adhesions. A recent study advocated by Tuncel et al, concluded that combined use of autologous fat graft with surgical repair methods induced significantly better regeneration in rats \[3\]. In another study by Kilic et al, using adipose tissue flap in a crush injury model in rats was found to be superior to other groups in myelin thickness, nerve fiber density, axon count, and functional recovery at 4 weeks. They concluded that fat tissue seems to promote nerve regeneration because of its stem cell content. To our knowledge, no prior studies have examined the use of fat graft in peripheral nerve repair in humans. So, the investigators proposed this clinical study to evaluate the outcomes of primary nerve repair combined with autologous fat graft in peripheral nerve injuries.

Official TitleUse of Autologous Fat to Improve Functional Outcomes After Upper Limb Nerve Injuries
NCT04653129
Principal SponsorAssiut University
Study ContactAhmed S Sharaf, MsC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesWounds and InjuriesTrauma, Nervous SystemPeripheral Nerve Injuries

Criteria

Inclusion Criteria: \- Acute median or ulnar nerve lacerations below elbow Exclusion Criteria: * Old Nerve lacerations \> 48 hours * Nerve gap which requires nerve grafting * Psychosocial issues that would limit participation and compliance

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope with autologous fat grafting around site of repair

Group II

Active Comparator
Standard nerve repair will be performed with 9/0 nylon sutures, under magnification by an operating microscope without fat grafting.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers