Effect of Plasma Derived Exosomes on Cutaneous Wound Healing

• ClinicalTrials.gov Identifier: NCT02565264
• Recruitment Status: Enrolling by invitation
• First Posted: October 1, 2015
• Last Update Posted: August 28, 2018
• Sponsor: Kumamoto University
• Information provided by (Responsible Party): Kumamoto University

Tracking Information

• First Submitted Date: September 23, 2015
• First Posted Date: October 1, 2015
• Last Update Posted Date: August 28, 2018
• Study Start Date: September 2015
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT02565264 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: September 30, 2015): Pain of cutaneous wounds (Visual Analog Score for pain) [ Time Frame: 28 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ulcer

Intervention

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

Experimental: plasma-derived exosomes

plasma-derived exosomes

Intervention: Other: plasma-derived exosomes

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: September 30, 2015): 5
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2019
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT02565264
• Other Study ID Numbers: 2012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kumamoto University
• Study Sponsor: Kumamoto University
• Collaborators: Not Provided

Investigators

• 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