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Trial record 1 of 1 for:    NCT02565264
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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 : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Kumamoto University

Brief Summary:
This study is an open prospective clinical trial. The objective is to evaluate the effect of autologous exosomes rich plasma on cutaneous wound healing. The participants are patients with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns). The participants will be treated autologous exosomes rich plasma every day for 28 days. The cutaneous wound healing will be evaluated by the length, width and depth of the wound.

Condition or disease Intervention/treatment Phase
Ulcer Other: plasma-derived exosomes Early Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Plasma Derived Exosomes on Intractable Cutaneous Wound Healing: Prospective Trial
Study Start Date : September 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: plasma-derived exosomes
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.




Primary Outcome Measures :
  1. Ulcer size (length, mm) [ Time Frame: 28 days ]
  2. Ulcer size (width, mm) [ Time Frame: 28 days ]
  3. Ulcer size (depth, mm) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Pain of cutaneous wounds (Visual Analog Score for pain) [ Time Frame: 28 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns)

Exclusion Criteria:

  1. Patients who have ulcers with bone involvement.
  2. Patients who have ulcers with a history or suspected neoplasia.
  3. Patients who are in chemotherapy or radiation therapy on the skin ulcers.
  4. Patients with marked immunodeficiency (i.e., patients with severe liver failure, heart failure, hematologic failure or endocrine failure)
  5. Patients who have clinical signs of malnutrition or serum albumin <2 mg / dL.
  6. Patients who have severe infection.
  7. Patients who are pregnant or breastfeeding.
  8. Patients who are participating in another study.
  9. Patients who are judged inappropriate for this trial by their attending physician.

Information from the National Library of Medicine

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


Locations
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Japan
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Investigators
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Principal Investigator: Jinnin Masatoshi, MD, PhD Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University

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Responsible Party: Kumamoto University
ClinicalTrials.gov Identifier: NCT02565264     History of Changes
Other Study ID Numbers: 2012
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018