Effect of Plasma Derived Exosomes on Cutaneous Wound Healing

NCT02565264 | Unknown Early Phase 1

• 1 other identifier: 2012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer

Outcome Measures

Primary Outcomes (3)

• Ulcer size (length, mm)

  28 days

• Ulcer size (width, mm)

  28 days

• Ulcer size (depth, mm)

  28 days

Secondary Outcomes (1)

• Pain of cutaneous wounds (Visual Analog Score for pain)

  28 days

Study Arms (1)

plasma-derived exosomes

EXPERIMENTAL

plasma-derived exosomes

Other: plasma-derived exosomes

Interventions

plasma-derived exosomes OTHER

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.

plasma-derived exosomes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kumamoto University: lead

Study Sites (1)

Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University

Kumamoto, 860-8556, Japan

Location

MeSH Terms

Conditions

Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinnin Masatoshi, MD, PhD

  Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 1, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2019-09

Locations

JP (1)