Condition category
Nervous System Diseases
Date applied
23/11/2016
Date assigned
02/12/2016
Last edited
25/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Migraine is one of the most common neurological conditions affecting around 18% of women and 6% of men. About 2% of the population suffers from very debilitating migraines. Despite recent progress in the treatment of migraines, many sufferers cannot be helped, leading to severe disability. This study attempted to help those patients who did not respond to multiple migraine drugs and procedures, including Botox injections. Stem cells have been the subject of intensive research for the past two decades and one of the discoveries has been the strong anti-inflammatory properties of stem cells. Since migraine involves inflammation of the surface coverings of the brain, it is reasonable to assume that stem cells could relieve migraines. The richest source of stem cells in human body is fat. The aim of this study is to investigate the effectiveness treating migraine sufferers with stem cells derived from their own body fat.

Who can participate?
Adults who suffer from long-term difficult-to-treat migraines.

What does the study involve?
The participants in this study are asked to keep a daily headache diary starting a month before the procedure and for 3 months after it. The study procedure involves the collection of fat using standard liposuction procedures, which is then spun very quickly in a special machine (centrifuge) to separate the stem cell-rich part of fat. This is then injected into the muscles around the head and neck.

What are the possible benefits and risks of participating?
Benefits not provided at time of registration. There are no notable risks involved with participating other than the standard risks associated with liposuction and injections into muscles, such as bruising, bleeding, infection, and cosmetic side effects.

Where is the study run from?
New York Headache Center (USA)

When is the study starting and how long is it expected to run for?
January 2015 to June 2016

Who is funding the study?
MicroAire (USA)

Who is the main contact?
Dr Alexander Mauskop
drmauskop@nyheadache.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexander Mauskop

ORCID ID

Contact details

New York Headache Center
30 East 76 Street
2nd Floor
New York
10021
United States of America
+1 212 794 3550
drmauskop@nyheadache.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Open label study to assess safety and efficacy of autologous adipose derived stromal vascular fraction (SVF) cells for the treatment of refractory migraine headaches

Acronym

Study hypothesis

Anti-inflammatory properties of stem cells suggest that they may be effective in the treatment of migraine headaches since neurogenic inflammation is an important part of migraine pathogenesis

Ethics approval

New England Institutional Review Board, 26/06/2015, ref: 15-236

Study design

Open label non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Chronic migraine, refractory to treatment

Intervention

On all participants, liposuction is performed under local anesthesia to obtain approximately 500 ml of adipose tissue. This tissue is then centrifuged to separate stromal vascular fraction (SVF). The SVF is then injected into the pericranial muscles of the participants. The entire procedure, including the liposuction and the injections lasts for 2 to 3 hours.

All participants are followed up monthly for at least three months following the procedure.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

Change in migraine-related disability, as measured by patient-reported Migraine Disability Assessment (MIDAS) score, in the three months following the procedure.

Secondary outcome measures

1. The change in impact of headaches as measured by the Headache impact score (HIT-6) in the third month compared to the month prior to the procedure
2. Patient's global impression of change is measured using a standard verbal scale at baseline and 3 months after the procedure
3. Clinician’s global Impression of change is measured using a standard verbal scale at baseline and 3 months after the procedure
4. Number of headache-free days are measured using a daily diary in the month preceding the procedure and in the third month following the procedure
5. Percentage of patients with 50% or greater reduction in headache-free days is measured using a daily diary in the month preceding the procedure and in the third month following the procedure
6. Number and type of abortive migraine medications taken is measured using a daily diary in the month preceding the procedure and in the third month following the procedure

Overall trial start date

01/01/2015

Overall trial end date

20/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Suffer from refractory chronic migraines, defined as patients with severe migraine-related disability as measured by the migraine disability assessment (MIDAS) score
3. Failed to respond to at least 3 prophylactic medications and onabotulinumtoxinA

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Pregnancy
2. Low body mass index

Recruitment start date

26/06/2015

Recruitment end date

31/03/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

New York Headache Center
30 East 76 Street
New York
10021
United States of America

Sponsor information

Organisation

New York Headache Center

Sponsor details

30 East 76 Street
2nd Floor
New York
10021
United States of America
+1 212 794 3550
drmauskop@nyheadache.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

MicroAire

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be published in a peer-reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Alexander Mauskop, DrMauskop@NYHeadache.com

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in https://www.karger.com/Article/FullText/477393

Publication citations

Additional files

Editorial Notes

25/09/2017: Internal review. 06/07/2017: Internal review. 15/06/2017: Publication reference added.