None listed
Conditions
Brief summary
The primary objective of this study is to determine the safety and tolerability of SVF compared to placebo in patients with chronic migraine headaches. The secondary objective is to measure differences between placebo and SVF based therapies in several efficacy assessments including: improvement in migraine headache-free rates, migraine headache severity, duration, degree of disability associated symptoms, and use of concomitant headache medications in comparison to placebo.
Interventions
The primary objective of this study is to determine the safety and tolerability of stromal vascular fraction (SVF) compared to placebo in patients with chronic migraine headaches. The secondary objective is to measure differences between placebo and SVF.
Thirty participants will be enrolled in the study and randomly separated into 2 study groups.
Cohort 1: 15 patients administered with SVF (Day 0 and Day 30)
Cohort 2: 15 patients administered with placebo (Normal Saline; Day 0 and Day 30)
The primary objective of this study is to determine the safety and tolerability of stromal vascular fraction (SVF) compared to placebo in patients with chronic migraine headaches. The secondary objective is to measure differences between placebo and SVF. Thirty participants will be enrolled in the study and randomly separated into 2 study groups. Cohort 1: 15 patients administered with SVF (Day 0 and Day 30) Cohort 2: 15 patients administered with placebo (Normal Saline; Day 0 and Day 30) Autologous non-expanded SVF from adipose (fat) will be used due to the ease of harvest and safety (liposuction; about 60 min). The procedure will be performed by the Principle Investigator (Dr Ralph Bright - Physician and Cosmetic Surgeon), with the fat taken from the abdomen. Cohort 1: [study drug] will have a SVF intravenous (IV) infusion of 3 million cells/kg of body weight in 500ml of Normal Saline after undergoing liposuction for 200 - 300 ml of adipose tissue (excess SVF will be cryo-preserved for the repeat treatment at Day 30). The fat is processed on-site to isolate the cells (this process takes up to 40 mins approximately), and an infusion of SVF occurs immediately once the fat processing has finished. Cohort 2: [placebo] will have an intravenous (IV) infusion of 500ml of Normal Saline (placebo), packaged in the same way as SVF after undergoing liposuction for 200 - 300 ml of adipose tissue (IV administration will be repeated on Day 30). SVF will be separated from the adipose tissue and cryo-preserved for the placebo group as an option for treatment after the study.
Sponsors
Cell-Innovations
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Chronic migraine (satisfying the International Classification of Headache Disorders (ICHD-2R) criteria). The ICHD-2R defines chronic migraine as more than fifteen headache days per month over a three month period of which more than eight are migrainous, in the absence of medication over use.
Exclusion criteria
1. Participants who have received investigational agents within 4 weeks (or 5 half-lives) of treatment. 2. Subjects with significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of the study. 3. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders. 4. Participants who have had active neoplastic disease (cancer) in the previous 3 years. 5. Presence of active infection (except for colds or minor URTI). History of human immunodeficiency virus or acquired immune deficiency syndrome. Significant peripheral vascular disease. 6. Participants who are pregnant or lactating. Female participants who have positive serum beta HCG pregnancy test taken within 7 days before treatment. 7. Fertile participants who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures). 8. Previous treatment with SVF. 9. Conditions/therapies/factors which could confound or interfere with the evaluation of pain including but not limited to: a) Treatments with strong opioid drugs in the previous 60 days for pain b) Procedures planned during the study period which could interfere with pain assessment (e.g. surgery) c) Other causes of chronic pain (e.g. neck pain) 10. Use of anticoagulant medication 11. Consistent use of NSAIDs within 48 hours of procedure. 12. Aspirin (except at low dose for cardioprotection), Vitamin E, Fish Oil, krill oil or anti-inflammatories for one week prior 13. Insufficient fat present for liposuction. 14. Inability to understand the study or complete headache diary/ SF-36 questionnaires. 15. Allergic to dimethyl sulfoxide (DMSO) 16. Inability to provide informed consent
Outcome results
None listed