. 2023 Mar 7;12(3):179–188. doi: 10.1302/2046-3758.123.BJR-2022-0383.R1

Table IV.

Overview of five clinical trials for the treatment of peripheral nerve injury of the upper limbs using decellularized tissue.

Trial no.	Condition	Clinical trial name	Length	Status	Product name	Source tissue	Country	Hospital/Company	Clinical reports	Decellularization method/sterilization method
N1	Peripheral nerve injury of upper limb	A comparative post-marketing study of commercially available peripheral nerve gap repair options	2009 to 2014	Terminated (transitioning from 361 HCT/P Tissue to a Biological (BLA))	Avance nerve graft	Human peripheral nerve	USA	Georgia Hand, Shoulder and Elbow, Indiana Hand Centre, University of Kentucky/Axogen Corporation	Safa³⁴	50 mM phosphate + 100 nM Na, 0.14% Triton X-200, 0.6 mM sulfobetaine-16/gamma irradiation³⁵
N2	Peripheral nerve injury of upper limb	Human acellular nerve graft for repair of peripheral nerve defects: a prospective, multicentre clinical study	2009 to 2017	Completed	N/A	Human peripheral nerve	China	The Sixth Affiliated Hospital of Shanghai Jiao Tong University /Guangzhou Zhongda Medical Devices Company	Zhu³⁶	46 mM Triton X-100, 96 mM sodium deoxycholate;³⁶ N/A
N3	Peripheral nerve injury of upper limb	Human acellular nerve graft for repair of pure sensory nerve defects: a prospective, multicentre clinical study	2009 to 2017	Completed	N/A	Human peripheral nerve	China	The First Affiliated Hospital of Sun Yat-sen University/Guangzhou Zhongda Medical Devices Company	Zhu³⁶	46 mM Triton X-100, 96 mM sodium deoxycholate;³⁶ N/A
N4	Peripheral nerve injury of upper limb	Comparison of processed nerve allograft and collagen nerve cuffs for peripheral nerve repair (RECON)	2015 to 2021	Completed	Avance nerve graft	Human peripheral nerve	USA	Virginia Commonwealth University Medical Centre, University of Pennsylvania, University of Florida/Axogen Corporation	Axogen³⁷	50 mM phosphate + 100 nM Na, 0.14% Triton X-200, 0.6 mM sulfobetaine-16/gamma irradiation³⁵
N5	Peripheral nerve injury of upper limb	BMAC nerve allograft study	2017 to 2021	Unknown status (Previously: active, not recruiting)	Avance nerve graft	Human peripheral nerve	USA	Brooke Army Medical Centre, Walter Reed National Military Medical Centre, Curtis National Hand Centre at MedStar Union Memorial Hospital/Axogen Corporation	Safa³⁴	50 mM phosphate + 100 nM Na, 0.14% Triton X-200, 0.6 mM sulfobetaine-16/gamma irradiation³⁵
N6	Peripheral nerve injury of upper limb	Use of a nerve regeneration conduit (NerVFIX) in the treatment of nerve section of the wrist	2020 to 2023	Recruiting	NerVFIX	Human artery or vein from umbilical cord	France	Clinique de la Main - Nantes Atlantique, Institut Chirurgical de la Main et du Membre Supérieur/TBF Genie Tissulaire	Barnouin³⁸	N/A; gamma irradiation (25 to 32 kGy), freezing³⁹

BLA, biologic license application; BMAC, bone marrow aspirate concentrate; CM, carpometacarpal; HCT/P, human cell & tissue products; N/A, not available.