A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain

NCT05756595 | Completed DMC

• 1 other identifier: hui19590204
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain; Neck Pain; Back Pain; Temporal Pain; Herpes Zoster Pain

Keywords

hyaluronidase; Hyaluronan; 35kDa Hyaluronan fragment; pain caused by herpes zoster; pain caused by shoulder neck back and temporal

Outcome Measures

Primary Outcomes (1)

• Pain scores of all shoulder, neck, back, temporal and herpes zoster pain

  The pain scale is a tool that doctors use to help assess patients' pain. Each patient rated their pain on a scale of 0 to 10. 0 means "no pain" and 10 means "the most painful". Statistical t-test was used to calculate and evaluate the pain intensity, which was expressed as mean ±standard deviation.

  3 hours

Study Arms (1)

35kDa hyaluronan fragment HA35 injection

EXPERIMENTAL

100 mg Hyaluronan is locally injected at the pain point or where the nerve trunk is innervated by the pain point.

Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)

Interventions

HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) DRUG

This group will inject once a week. Evaluation of pain score after 30 seconds and 3 hours.

Also known as: HA35

35kDa hyaluronan fragment HA35 injection

Eligibility Criteria

• Age: 39 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Shoulder, neck, back and temporal pain. The course of the disease ranged from 0 to 8 months.
• Herpes zoster pain. The course of 0-2 months.

You may not qualify if:

• Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors)

Sponsors & Collaborators

• Dove Medical Press Ltd: lead
• The Affiliated Hospital of Qingdao University: collaborator
• Nakhia Impex LLC: collaborator

Study Sites (1)

Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

Location

Related Publications (2)

• Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.

  PMID: 36686276 RESULT

• APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Shoulder Pain; Neck Pain; Back Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A self-controlled an open label clinical study(An investigator-initiated off-label use clinical study)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: A self-controlled an open label clinical study(An investigator-initiated off-label use clinical study)

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 6, 2023
• Study Start: July 6, 2020
• Primary Completion: December 29, 2022
• Study Completion: February 8, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: published precinical study and international granted patent
• Access Criteria: Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35); APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286

Locations

CN (1)