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