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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

Tracking Information
First Submitted Date  ICMJE September 23, 2015
First Posted Date  ICMJE October 1, 2015
Last Update Posted Date August 28, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • Ulcer size (length, mm) [ Time Frame: 28 days ]
  • Ulcer size (width, mm) [ Time Frame: 28 days ]
  • Ulcer size (depth, mm) [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02565264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Pain of cutaneous wounds (Visual Analog Score for pain) [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
Official Title  ICMJE Effect of Plasma Derived Exosomes on Intractable Cutaneous Wound Healing: Prospective Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: plasma-derived exosomes
plasma-derived exosomes
Intervention: Other: plasma-derived exosomes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565264
Other Study ID Numbers  ICMJE 2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kumamoto University
Study Sponsor  ICMJE Kumamoto University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinnin Masatoshi, MD, PhD Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University
PRS Account Kumamoto University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP