Treatment of severe chronic migraines with injections of stem cells obtained from patients' own fat tissue

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72512465

Enrollment

Registered

2016-12-02

Start date

2015-06-26

Completion date

Unknown

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic migraine, refractory to treatment Nervous System Diseases Chronic migraine, refractory to treatment

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Low body mass index

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026