The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine

September 26, 2022 updated by: Neurological Associates of West Los Angeles
The present study is being undertaken as a phase I study to determine the safety and feasibility of using adipose derived mesenchymal stem cell preparations (MSC) for treatment of CM. Intravenous and locally targeted stem cell treatment have already been reported in the context of treating various chronic pain conditions with early evidence of efficacy and a good safety profile. The treatment of CM is based on the model for treatment with botulinum where superficial facial and cranial injections are utilized. In addition, stem cells can be given intravenously as well.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic migraine (CM) is a disabling complex neurological disorder recognized as a complication of migraine in the the International Classification of Headache Disorders. Patients with CM experience headache on 15 days per month. CM is associated with significant disability and reduced health-related quality of life. Approximately 1.3% to 2.4% of the general population suffers from CM, and one in five CM sufferers cannot work because this condition impacts their ability to lead productive lives. CM is frequently complicated by overuse of acute pain medications. Some drugs have regulatory approval for migraine prophylaxis; none are approved specifically for CM prophylaxis although recently, botulinum injection has been FDA approved for CM treatment with marginal treatment effects with many patients failing to have complete remission. The present study is being undertaken as a phase I study to determine the safety and feasibility of using adipose derived mesenchymal stem cell preparations (MSC) for treatment of CM.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Los Angeles

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must exhibit symptoms that satisfy criteria of Chronic Migraine (e.g., experiencing headaches at least 15 days per month to a degree that is associated with significant disability and reduced health-related quality of life).

Exclusion Criteria:

  • Advanced stages of any terminal illness or active cancer that requires chemotherapy.
  • Pregnancy, women who may become pregnant or are breastfeeding.
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deployment of AD-SVF
Administration of autologous adipose derived SVF
Other: AD-SVF
Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.
Other Names:
  • Mesenchymal Stem Cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Event Reporting
Time Frame: Throughout study duration (Baseline through 36 months)
Any participants with adverse events suspected to be related to either SVF deployment or the lipo-harvesting procedure were noted and reported immediately.
Throughout study duration (Baseline through 36 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Headache Diary
Time Frame: 2 months
Headache pain is scored on a range from 0 'no pain' to 10 'worst pain ever.' Patients reported the number of headaches total per month (each diary has a total possible number of 31 entries).Total score is calculated by adding the sum score of each headache (maximum possible = 310). Clinical improvement was noted for patients whose scores improved by at least 20%.
2 months
Headache Impact Test (HIT-6)
Time Frame: 2 months
The HIT-6 is a self-report questionnaire consisting of 6 questions, with qualitative answers ranging from "never," "rarely," "sometimes," "very often," and "always" to describe the frequency and impact of headaches on patient lives. Answers correspond with point values as following: never = 6 points, rarely = 8 points, sometimes = 10 points, very often = 11 points, & always = 13 points. A total score of 50 or more indicates severe disability related to headaches. Clinical improvement was noted for patients who reported at least a 20% decrease in their scores from baseline.
2 months
Headache Diary
Time Frame: 6 months
Headache pain is scored on a range from 0 'no pain' to 10 'worst pain ever.' Patients reported the number of headaches total per month (each diary has a total possible number of 31 entries).Total score is calculated by adding the sum score of each headache (maximum possible = 310). Clinical improvement was noted for patients whose scores improved by at least 20% from baseline.
6 months
Headache Impact Test (HIT-6)
Time Frame: 6 months
The HIT-6 is a self-report questionnaire consisting of 6 questions, with qualitative answers ranging from "never," "rarely," "sometimes," "very often," and "always" to describe the frequency and impact of headaches on patient lives. Answers correspond with point values as following: never = 6 points, rarely = 8 points, sometimes = 10 points, very often = 11 points, & always = 13 points. A total score of 50 or more indicates severe disability related to headaches. Clinical improvement was noted for patients who reported at least a 20% decrease in their scores from baseline.
6 months
Headache Diary
Time Frame: 1 year
Headache pain is scored on a range from 0 'no pain' to 10 'worst pain ever.' Patients reported the number of headaches total per month (each diary has a total possible number of 31 entries).Total score is calculated by adding the sum score of each headache (maximum possible = 310). Clinical improvement was noted for patients whose scores improved by at least 20% from baseline.
1 year
Headache Impact Test (HIT-6)
Time Frame: 1 year
The HIT-6 is a self-report questionnaire consisting of 6 questions, with qualitative answers ranging from "never," "rarely," "sometimes," "very often," and "always" to describe the frequency and impact of headaches on patient lives. Answers correspond with point values as following: never = 6 points, rarely = 8 points, sometimes = 10 points, very often = 11 points, & always = 13 points. A total score of 50 or more indicates severe disability related to headaches. Clinical improvement was noted for patients who reported at least a 20% decrease in their scores from baseline.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurological Associates of West Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cell Surgical Network Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sheldon E Jordan, MD, FAAN, 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICSS-2018-014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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