Clinical trial NCT04064879: The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
Official title: The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Chronic Migraine, Headache
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
Collaborators: name: Cell Surgical Network Inc.
First posted: 2019-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Event Reporting
timeFrame: Throughout study duration (Baseline through 36 months)
Secondary outcomes:
measure: Headache Diary
timeFrame: 2 months
measure: Headache Impact Test (HIT-6)
timeFrame: 2 months
measure: Headache Diary
timeFrame: 6 months
measure: Headache Impact Test (HIT-6)
timeFrame: 6 months
measure: Headache Diary
timeFrame: 1 year
measure: Headache Impact Test (HIT-6)
timeFrame: 1 year
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon E Jordan, MD, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
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