The Use of Exosomes In Craniofacial Neuralgia

September 26, 2022 updated by: Neurological Associates of West Los Angeles
This study is designed to evaluate the safety and efficacy of exosome deployment in patients with Craniofacial Neuralgia. Secondarily, this study is designed to rigorously evaluate for any adverse events that may be related to the administration and reception of exosomes.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

The present study is designed to amplify the delivery of growth factors and anti-inflammatory agents to localized targets (determined by specific condition) by using focused transcranial ultrasound prior to intravenous infusion of exosomes. Exosomes delivered intravenously can be demonstrated to cross the blood brain barrier naturally. Exosomes are thought to play a normal physiological role in intercellular signaling, and demonstrate anti-inflammatory and pro-growth effects in preclinical models and clinical cases reports. Clinical trials have deployed exosomes intravenously and with intracerebral and intrathecal injection, and have claimed safety and clinical efficacy.

Focused ultrasound has been shown to enhance local blood flow and has been presented as a non-invasive means of targeting delivery of therapeutic agents.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Neurological Associates of West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female at least 18 years of age
  • Clinical diagnosis of craniofacial neuralgia

Exclusion Criteria:

  • Subjects unable to give informed consent
  • Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
  • Recent surgery or dental work within 3 months of the scheduled procedure.
  • Pregnancy, women who may become pregnant or are breastfeeding
  • Advanced terminal illness
  • Any active cancer or chemotherapy
  • Bone marrow disorder
  • Myeloproliferative disorder
  • Sickle cell disease
  • Primary pulmonary hypertension
  • Immunocompromising conditions and/or immunosuppressive therapies
  • Macular degeneration
  • Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
  • Advanced kidney, pulmonary, cardiac or liver failure
  • Subjects with vascular causes of dementia
  • Bleeding disorder, untreated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment of Craniofacial Neuralgia
All patients will receive the same amount (5mL concentrated) of exosomes delivered via ultrasound-guided, regional epineural injection and the same amount (5mL unconcentrated) delivered via IV. Patients will be given 3 mL of the exosome product intravenously, which contains about 45mg of the exosome product containing 15-21 million neonatal stem cell products, and 3 mL of the exosome hyperconcentrate product delivered epineurally using ultrasound guidance, which contains about 15mg of the exosome product carrying 5-7 million neonatal stem cell products.
Other: Exosomes
Focused ultrasound delivery of intravenously-infused exosomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: 8 weeks from baseline
The BPI is a 9 item self-report questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
8 weeks from baseline
Patient Health Questionnaire (PHQ-9)
Time Frame: 8 weeks from baseline
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total possible score is 27 points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
8 weeks from baseline
Adverse Event Reporting
Time Frame: Baseline to 24 weeks
Adverse events (AEs) and any other untoward signs or symptoms were collected at each study timepoint starting at the treatment injection. Serious adverse events (SAEs) determined by the investigator to be related to the study treatment were formally recorded.
Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change (GRC)
Time Frame: 8 weeks from baseline
The GRC is a self-administered one-item Likert scale questionnaire on the patient's overall satisfaction with the treatment; with scores from "-5" (very much worse) to "+5" (very much better). A GRC of at least is considered to be clinically significant improvement.
8 weeks from baseline
Brief Pain Inventory (BPI)
Time Frame: 24 weeks from baseline
The BPI is a 9 item self-report questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Self-report measure containing a composite pain score and functional interference score. The pain subscale contains 4 questions, each with answers ranging from 0 'no pain' to 10 'pain as bad as you can imagine.' Total possible score for the pain subscale is 40 points. The functional/interference subscale contains 7 questions, with each answer ranging from 0 'does not interfere' to 10 'completely interferes.' The maximum possible score for the interference subscale is 70 points. The total overall composite BPI score is out of 100 maximum points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
24 weeks from baseline
Patient Health Questionnaire (PHQ-9)
Time Frame: 24 weeks from baseline
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total possible score is 27 points. A clinical improvement is considered a decrease in BPI overall composite score by at least 30% from baseline.
24 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurological Associates of West Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2023

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICSS-2019-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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