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

NCT ID: NCT04064879

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2023-08-16

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.

Conditions

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Chronic Migraine, Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deployment of AD-SVF

Administration of autologous adipose derived SVF

Group Type EXPERIMENTAL

AD-SVF

Intervention Type OTHER

Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.

Interventions

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AD-SVF

Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.

Intervention Type OTHER

Other Intervention Names

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Mesenchymal Stem Cells

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cell Surgical Network Inc.

INDUSTRY

Sponsor Role collaborator

Neurological Associates of West Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheldon E Jordan, MD, FAAN

Role: PRINCIPAL_INVESTIGATOR

Neurological Associates of West Los Angeles

Locations

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Neurological Associates of West Los Angeles

Santa Monica, California, United States

Site Status

Countries

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United States

References

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Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.

Reference Type BACKGROUND
PMID: 14979299 (View on PubMed)

Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel 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. doi: 10.1111/j.1468-2982.2006.01172.x.

Reference Type BACKGROUND
PMID: 16686915 (View on PubMed)

Dodick DW. Clinical practice. Chronic daily headache. N Engl J Med. 2006 Jan 12;354(2):158-65. doi: 10.1056/NEJMcp042897. No abstract available.

Reference Type BACKGROUND
PMID: 16407511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18711108 (View on PubMed)

Castillo J, Munoz P, Guitera V, Pascual J. Kaplan Award 1998. Epidemiology of chronic daily headache in the general population. Headache. 1999 Mar;39(3):190-6. doi: 10.1046/j.1526-4610.1999.3903190.x.

Reference Type BACKGROUND
PMID: 15613213 (View on PubMed)

Scher AI, Stewart WF, Liberman J, Lipton RB. Prevalence of frequent headache in a population sample. Headache. 1998 Jul-Aug;38(7):497-506. doi: 10.1046/j.1526-4610.1998.3807497.x.

Reference Type BACKGROUND
PMID: 15613165 (View on PubMed)

Lanteri-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. doi: 10.1016/s0304-3959(02)00348-2.

Reference Type BACKGROUND
PMID: 12620605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20164501 (View on PubMed)

Diener HC, Limmroth V. Medication-overuse headache: a worldwide problem. Lancet Neurol. 2004 Aug;3(8):475-83. doi: 10.1016/S1474-4422(04)00824-5.

Reference Type BACKGROUND
PMID: 15261608 (View on PubMed)

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. doi: 10.1212/01.wnl.0000137039.08724.18.

Reference Type BACKGROUND
PMID: 15365134 (View on PubMed)

Lipton RB, Bigal ME. Chronic daily headache: is analgesic overuse a cause or a consequence? Neurology. 2003 Jul 22;61(2):154-5. doi: 10.1212/wnl.61.2.154. No abstract available.

Reference Type BACKGROUND
PMID: 12874389 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 21592099 (View on PubMed)

Other Identifiers

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ICSS-2018-014

Identifier Type: -

Identifier Source: org_study_id

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