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Chronic Migraine, HeadacheNCT04064879

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

A study testing AD-SVF in people with Chronic Migraine, Headache, run by Neurological Associates of West Los Angeles at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Migraine, Headache
What is being tested?
AD-SVF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
16 Aug 2018to 16 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Advanced stages of any terminal illness or active cancer that requires chemotherapy.
  • Pregnancy, women who may become pregnant or are breastfeeding.
  • Bleeding disorder, untreated.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Neurological Associates of West Los Angeles

    Santa Monica, California, 90403

Other trials in United States

About this study

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.

Read the 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.

Being tested
AD-SVF
Medical subject headings
Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AD-SVFOther

    Also called Mesenchymal Stem Cells

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

Study groups in NCT04064879
Study groupRoleWhat they receive
Deployment of AD-SVFExperimentalAdministration of autologous adipose derived SVF
Receives: Other: AD-SVF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Throughout study duration (Baseline through 36 months)

Secondary outcomes (6)

  1. 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%.

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 1 year

  6. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start16 Aug 2018
  3. Primary completion15 Aug 2023 (estimated)
  4. Study completion16 Aug 2023 (estimated)

Why it stopped: Pending FDA approval

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064879
Sponsor's protocol ID
ICSS-2018-014
Status last verified
Sep 2022
First submitted
19 Aug 2019
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 14979299

  • 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.

    PubMed 16686915

  • 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.

    PubMed 16407511

  • 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.

    PubMed 18711108

  • 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.

    PubMed 15613213

  • 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.

    PubMed 15613165

  • 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.

    PubMed 12620605

  • 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.

    PubMed 20164501

  • 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.

    PubMed 15261608

  • 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.

    PubMed 15365134

  • 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.

    PubMed 12874389

  • 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.

    PubMed 21592099

Questions about this trial

What is this clinical trial studying?

A study testing AD-SVF in people with Chronic Migraine, Headache, run by Neurological Associates of West Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event Reporting (time frame: Throughout study duration (Baseline through 36 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04064879, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

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