Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
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|ClinicalTrials.gov Identifier: NCT02565264|
Recruitment Status : Enrolling by invitation
First Posted : October 1, 2015
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcer||Other: plasma-derived exosomes||Early Phase 1|
Exosomes are small vesicles 0.03-0.1 μm in size, which are shed from most cell types into the extracellular space via intracellular endocytosis. They are found abundantly in body fluids such as blood. They consist of lipid bilayer so that their structure is stable. They can be preserved for 2 weeks at 4℃. They contain proteins, lipids and nucleic acids including coding or non-coding RNA. Resent studies have revealed that exosomes have an important role in cell-to-cell communication.
The investigators found that serum exosome levels were significantly decreased in scleroderma patients with vascular involvements such as cutaneous ulcers and/or pitting scars compared to in normal subjects. The investigators also elucidated that serum-derived exosomes accelerated cutaneous wound healing in BALB/c mice. Exosome supplementation to cutaneous ulcers seems to have significant therapeutic value.
The objective of present study is to evaluate the effect of exosomes derived from plasma on intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns).
Autologous exosomes are obtained from the participants' own plasma. The duration of study is 28days. The cutaneous wound healing will be evaluated at day1, day2, day7, day14, day 21 day 28.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Plasma Derived Exosomes on Intractable Cutaneous Wound Healing: Prospective Trial|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: plasma-derived exosomes
Other: plasma-derived exosomes
Plasma samples from the participants will be filtered through 0.45 μm and 0.20 μm filters. The samples will be filtered through 0.02 μm filter to trap exosomes with the filter. Saline solution will be loaded from the other side of the 0.02 μm filter to obtain exosome rich buffer. The plasma-derived exosomes will be applied to the participants' ulcers daily for 28 days.
- Ulcer size (length, mm) [ Time Frame: 28 days ]
- Ulcer size (width, mm) [ Time Frame: 28 days ]
- Ulcer size (depth, mm) [ Time Frame: 28 days ]
- Pain of cutaneous wounds (Visual Analog Score for pain) [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565264
|Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University|
|Kumamoto, Japan, 860-8556|
|Principal Investigator:||Jinnin Masatoshi, MD, PhD||Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University|