NCT04064879

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

August 19, 2019

Last Update Submit

September 26, 2022

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (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.

    Throughout study duration (Baseline through 36 months)

Secondary Outcomes (6)

  • Headache Diary

    2 months

  • Headache Impact Test (HIT-6)

    2 months

  • Headache Diary

    6 months

  • Headache Impact Test (HIT-6)

    6 months

  • Headache Diary

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Deployment of AD-SVF

EXPERIMENTAL

Administration of autologous adipose derived SVF

Other: AD-SVF

Interventions

AD-SVFOTHER

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

Also known as: Mesenchymal Stem Cells
Deployment of AD-SVF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurological Associates of West Los Angeles

Santa Monica, California, 90403, United States

Location

Related Publications (12)

  • 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.

    PMID: 14979299BACKGROUND

  • 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.

    PMID: 16686915BACKGROUND

  • 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.

    PMID: 16407511BACKGROUND

  • 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.

    PMID: 18711108BACKGROUND

  • 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.

    PMID: 15613213BACKGROUND

  • 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.

    PMID: 15613165BACKGROUND

  • 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.

    PMID: 12620605BACKGROUND

  • 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.

    PMID: 20164501BACKGROUND

  • 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.

    PMID: 15261608BACKGROUND

  • 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.

    PMID: 15365134BACKGROUND

  • 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.

    PMID: 12874389BACKGROUND

  • 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.

    PMID: 21592099BACKGROUND

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sheldon E Jordan, MD, FAAN

    Neurological Associates of West Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 22, 2019

Study Start

August 16, 2018

Primary Completion

August 15, 2023

Study Completion

August 16, 2023

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

US(1)