Chronic Migraine, Headache
Conditions
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.
Interventions
OTHERAD-SVF
Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.
Sponsors
Cell Surgical Network Inc.
Neurological Associates of West Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Reporting | Throughout study duration (Baseline through 36 months) | Any participants with adverse events suspected to be related to either SVF deployment or the lipo-harvesting procedure were noted and reported immediately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache Diary | 2 months | 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%. |
| Headache Impact Test (HIT-6) | 2 months | 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. |
Countries
United States
Outcome results
None listed