A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain
Status:
Completed
Trial end date:
2023-02-08
Target enrollment:
Participant gender:
Summary
Local used high molecular weight Hyaluronan (HA) with high viscosity has a variety of
receptors in the human body, including CD44, LYVE-1, RHAMM, HARE, Siglec-9, TLR2, CEMIP and
TMEM2. Intra-articular local injection of HA has a certain degree of analgesic effect. Local
injection of HA into the nerve trunk directed by ultrasound was used for the treatment of
neuropathic pain. It was reported that the analgesic effect of HA is regulated by TRPV1 ion
channels. This study hypothesizes that hyaluronidase cleaves HA to generate low molecular
weight HA fragments HA35 with good tissue permeability, which may bind to a variety of HA
receptors on the cell surface within the tissues and produce a broad-spectrum analgesic
effect. In this study, 35kDa Hyaluronan fragment HA35 was prepared by mixing hyaluronidase
PH20 injection and high molecular weight Hyaluronan (HA) injection at room temperature for 20
minutes. In this study, hyaluronidase injection and Hyaluronan injection were off-label used
to conduct an investigator-initiated study (IIT or IIS) for the treatment of herpes zoster
and shoulder, neck, back and temporal pain.
Phase:
N/A
Details
Lead Sponsor:
Dove Medical Press Ltd
Collaborators:
Nakhia Impex LLC The Affiliated Hospital of Qingdao University