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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Migraine, Headache

Intervention / Treatment
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* Other: AD-SVF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deployment of AD-SVF<br>Administration of autologous adipose derived SVF | Other: AD-SVF<br>* Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.<br>* Other names: Mesenchymal Stem Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Reporting | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Diary | 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) | 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 | 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) | 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 | 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) | 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 |