Autologous Fat in Peripheral Nerve Injury

Nerve Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04653129
• Other study ID #: Fat for Nerve Injury
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: January 2023

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: Ahmed S Sharaf, MsC
• Phone: 01090619155
• Email: ahmed.sharaf90[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the efficacy of autologous fat graft in enhancing peripheral nerve regeneration. The investigators hypothesize that fat grafting will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Injury
• Peripheral Nerve Injuries
• Wounds and Injuries

Intervention

Procedure:
• Autologous Fat Grafting
The fat grafts will be harvested from the abdomen or lateral thighs in a closed sterile system, then prepared according to Coleman guidelines. The blood and oil layers are then separated from the adipose tissue. The lipoaspirate will be injected based on a technique described by Vaienti et al, by 17-gaug cannula which will be inserted through the skin around the main incision at the nerve repair site, and the fat graft will be injected after closure of the skin.
• Primary Nerve Repair
Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Di Summa PG, Schiraldi L, Cherubino M, Oranges CM, Kalbermatten DF, Raffoul W, Madduri S. Adipose Derived Stem Cells Reduce Fibrosis and Promote Nerve Regeneration in Rats. Anat Rec (Hoboken). 2018 Oct;301(10):1714-1721. doi: 10.1002/ar.23841. Epub 2018 Jul 10. — View Citation

Iannace C, Di Libero L, Manetta F, Sciascia V, Pizza A, Napolitano S, Ferraro A, Scetta G, Esposito D, Varriale S, Candela G, Caracciolo F. [Coleman lipofilling: experience of an Italian group and review of the literature]. Chir Ital. 2009 Jan-Feb;61(1):67-75. Italian. — View Citation

Kilic A, Ojo B, Rajfer RA, Konopka G, Hagg D, Jang E, Akelina Y, Mao JJ, Rosenwasser MP, Tang P. Effect of white adipose tissue flap and insulin-like growth factor-1 on nerve regeneration in rats. Microsurgery. 2013 Jul;33(5):367-75. doi: 10.1002/micr.22101. Epub 2013 May 7. — View Citation

Ngeow WC. Scar less: a review of methods of scar reduction at sites of peripheral nerve repair. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):357-66. doi: 10.1016/j.tripleo.2009.06.030. Review. Erratum in: Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Aug;110(2):271. — View Citation

Tuncel U, Kostakoglu N, Turan A, Çevik B, Çayli S, Demir O, Elmas C. The Effect of Autologous Fat Graft with Different Surgical Repair Methods on Nerve Regeneration in a Rat Sciatic Nerve Defect Model. Plast Reconstr Surg. 2015 Dec;136(6):1181-91. doi: 10.1097/PRS.0000000000001822. — View Citation

Vaienti L, Gazzola R, Villani F, Parodi PC. Perineural fat grafting in the treatment of painful neuromas. Tech Hand Up Extrem Surg. 2012 Mar;16(1):52-5. doi: 10.1097/BTH.0b013e31823cd218. — View Citation

Walocko FM, Khouri RK Jr, Urbanchek MG, Levi B, Cederna PS. The potential roles for adipose tissue in peripheral nerve regeneration. Microsurgery. 2016 Jan;36(1):81-8. doi: 10.1002/micr.22480. Epub 2015 Sep 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified British Medical Research Council, sensory grading	standardized clinical assessment of sensory function using two-point discrimination and monofilament testing by a score from S0 to S4; the higher score indicates better sensation	6-12 months
Primary	Modified British Medical Research Council, motor grading	standardized clinical assessment of motor function on a scale from M0 to M5; the higher score indicates better strength.	6-12 months
Secondary	Nerve conduction study	measure for amplitude of response, latency of response and velocity of response measurements.	6-12 months
Secondary	Disability of the Arm, Shoulder, and Hand (DASH) score	self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100 (most severe disability)	6-12 months