The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deployment of AD-SVF Administration of autologous adipose derived SVF |
Other: AD-SVF
Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- Headache Diary [6 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% from baseline.
- Headache Impact Test (HIT-6) [6 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.
- Headache Diary [1 year]
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.
- Headache Impact Test (HIT-6) [1 year]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neurological Associates of West Los Angeles | Santa Monica | California | United States | 90403 |
Sponsors and Collaborators
- Neurological Associates of West Los Angeles
- Cell Surgical Network Inc.
Investigators
- Principal Investigator: Sheldon E Jordan, MD, FAAN, Neurological Associates of West Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
- Bigal ME, Lipton RB, Tepper SJ, Rapoport AM, Sheftell FD. Primary chronic daily headache and its subtypes in adolescents and adults. Neurology. 2004 Sep 14;63(5):843-7.
- Bigal ME, Serrano D, Reed M, Lipton RB. Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology. 2008 Aug 19;71(8):559-66. doi: 10.1212/01.wnl.0000323925.29520.e7.
- Buse DC, Manack A, Serrano D, Turkel C, Lipton RB. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry. 2010 Apr;81(4):428-32. doi: 10.1136/jnnp.2009.192492. Epub 2010 Feb 17.
- Castillo J, Muñoz P, Guitera V, Pascual J. Kaplan Award 1998. Epidemiology of chronic daily headache in the general population. Headache. 1999 Mar;39(3):190-6.
- Diener HC, Limmroth V. Medication-overuse headache: a worldwide problem. Lancet Neurol. 2004 Aug;3(8):475-83. Review.
- Dodick DW, Turkel CC, Degryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF. OnabotulinumtoxinA for treatment of chronic migraine: a response. Headache. 2011 Jun;51(6):1005-8. doi: 10.1111/j.1526-4610.2011.01925.x. Epub 2011 May 17.
- Dodick DW. Clinical practice. Chronic daily headache. N Engl J Med. 2006 Jan 12;354(2):158-65. Review. Erratum in: N Engl J Med. 2006 Feb 23;354(8):884.
- Headache Classification Committee, Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Göbel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6.
- Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160.
- Lantéri-Minet M, Auray JP, El Hasnaoui A, Dartigues JF, Duru G, Henry P, Lucas C, Pradalier A, Chazot G, Gaudin AF. Prevalence and description of chronic daily headache in the general population in France. Pain. 2003 Mar;102(1-2):143-9.
- Lipton RB, Bigal ME. Chronic daily headache: is analgesic overuse a cause or a consequence? Neurology. 2003 Jul 22;61(2):154-5.
- Scher AI, Stewart WF, Liberman J, Lipton RB. Prevalence of frequent headache in a population sample. Headache. 1998 Jul-Aug;38(7):497-506.
- ICSS-2018-014