Freshly Manufactured 35kDa Hyaluronan Fragment HA35 for the Treatment of Chronic Wounds
Condition: Chronic Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      In this research, the patients with chronic wounds accompanied by pain were treated by
      injecting freshly manufactured tissue permeable hyaluronan fragment HA35 into the tissue
      under the heath skin immediately surrounding the chronic wounds.
    

Detailed description: 
      Chronic wounds are wounds or ulcers that do not heal properly and are generally classified as
      venous, arterial, diabetic, traumatic, and pressure chronic wound. Persistent chronic
      inflammation is a hallmark for chronic wound or trauma and is also often associated with
      inflammatory and neuropathic pain.

      Injections of high molecular weight hyaluronan HA into joint cavity have been used for many
      years in treatment of joint pain as well as associated inflammation. Still, due to the high
      viscosity and poor tissue permeability of high molecular weight HA, it is unsuitable for
      treating chronic wound or trauma pain and the associated inflammation. In this study, the
      investigators found that hyaluronidase PH20 could cleave high molecular weight hyaluronan
      into 35kDa low molecular weight hyaluronan fragment HA35. The freshly-made hyaluronan
      fragment HA35 had great tissue permeability compared with high molecular HA. Our previous
      clinical studies (http://www.clinicaltrials.gov) have shown freshly-made hyaluronan fragment
      HA35 effectively treating shoulder, neck and back pain as well as the severe pain associated
      with shingles. In this study, the tissue-permeable 35kDa hyaluronan fragment HA35 was freshly
      manufactured by mixing hyaluronidase PH20 injectable solution and high-molecular-weight
      hyaluronan HA injectable solution. The therapeutic effect of the tissue-permeable hyaluronan
      fragment HA35 for treatment of pain associated chronic wounds was studied in a single-arm
      off-label used, before and after treatment comparison, clinical study similar to others.

      Both recombinant human hyaluronidase PH20 (Hylenex, Halozyme Inc) and bovine testis-derived
      hyaluronidase PH20 (H31022111) are able to cleave high molecule weight hyaluronan into 35 kDa
      hyaluronan fragments HA35 (L20200708MP07707, Ministry of Health, Mongolia). This clinical
      study uses 35kDa low molecular weight hyaluronan fragment HA35 which was freshly manufactured
      by mixing bovine testis-derived hyaluronidase PH20 injection (H31022111) with high molecular
      weight hyaluronan HA injection (H20174089) for 20 minutesat at room temperature.

      In this study, 20 hospitalized patients with chronic wounds accompanied by pain were treated
      with the freshly manufactured 35 kDa low molecular weight hyaluronan fragment HA35. There
      were 8 patients with diabetic chronic wounds, 4 patients with chronic venous wounds, 2
      patients with chronic arterial wounds, 6 patients with traumatic and chronic pressure wounds.
      Among these patients, there are 12 males and 8 females, having average age of 55±10 years.
      The creteria for the chronic wound in this study were the wound that has not been healed more
      than 3 months. All the chronic wounds were associated with significantly pain. All the wounds
      were clinically presented by surface darkenes and purulent secretions on the wounds, and
      darkness, redness, swelling and dryness and broken surface of the skin surrounding the
      wounds. This study is an open-label clinical study in which no information is withheld from
      participantes and investigators. In this study, the therapeutic effect was studied by
      comparison of those of before and after treatment in a single-arm study. The pain associated
      with the wounds and degree of healing of the wounds including the size of fresh granulation
      area on the wound, the degree of darkness or redness, dryness and broken surface of the skin
      surrounding the wound, and the size of the wound were observed and recorded.
    

Intervention name(s): HA35(L20200708MP07707, Ministry of Health, Mongolia)was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
Intervention type(s): Drug
Intervention description(s): One hundred milligrams of the freshly made 35 kDa low molecular weight HA fragment HA35 was injected into the tissue under the heath skin immediately surrounding the chronic wounds once a day for 10 days.
Other intervention name(s): HA35
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Intervention model description: An open label single arm before and after treatment comparison clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronidase; 35kDa hyaluronan fragment; HA35; Tissue permeability; Chronic wound; Wound healing