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Trial record 2 of 453 for:    cell surgical network

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064879
Recruitment Status : Suspended (Pending FDA approval)
First Posted : August 22, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Cell Surgical Network Inc.
Information provided by (Responsible Party):
Neurological Associates of West Los Angeles

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
Chronic Migraine, Headache Other: AD-SVF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Autologous Mesenchymal Stem Cell Preparation for Treatment of Refractory Migraine
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

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 Name: Mesenchymal Stem Cells




Primary Outcome Measures :
  1. Adverse Event Reporting [ Time Frame: 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 :
  1. Headache Diary [ Time Frame: 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%.

  2. Headache Impact Test (HIT-6) [ Time Frame: 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.

  3. Headache Diary [ Time Frame: 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.

  4. Headache Impact Test (HIT-6) [ Time Frame: 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.

  5. Headache Diary [ Time Frame: 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.

  6. Headache Impact Test (HIT-6) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064879


Locations
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United States, California
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
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Principal Investigator: Sheldon E Jordan, MD, FAAN Neurological Associates of West Los Angeles
Publications:

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Responsible Party: Neurological Associates of West Los Angeles
ClinicalTrials.gov Identifier: NCT04064879    
Other Study ID Numbers: ICSS-2018-014
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations