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Trial from ANZCTR

A randomised, placebo-controlled, double-blind, proof of concept study of the safety and efficacy of autologous stromal vascular fraction (SVF) cells, in patients with moderate to severe chronic migraine headache

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 10/5/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615001260516

Date registered

18 November 2015

Health condition

Chronic migraine

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

30 March 2016

Ethics application status

Approved

Brief summary

The primary objective of this study is to determine the safety and tolerability of SVF compared to placebo in patients with chronic migraine headaches.

The secondary objective is to measure differences between placebo and SVF based therapies in several efficacy assessments including: improvement in migraine headache-free rates, migraine headache severity, duration, degree of disability associated symptoms, and use of concomitant headache medications in comparison to placebo.

Eligibility

Key inclusion criteria

Chronic migraine (satisfying the International Classification of Headache Disorders (ICHD-2R) criteria). The ICHD-2R defines chronic migraine as more than fifteen headache days per month over a three month period of which more than eight are migrainous, in the absence of medication over use.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

1. Participants who have received investigational agents within 4 weeks (or 5 half-lives) of treatment.

2. Subjects with significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of the study.

3. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.

4. Participants who have had active neoplastic disease (cancer) in the previous 3 years.

5. Presence of active infection (except for colds or minor URTI). History of human immunodeficiency virus or acquired immune deficiency syndrome. Significant peripheral vascular disease.

6. Participants who are pregnant or lactating. Female participants who have positive serum beta HCG pregnancy test taken within 7 days before treatment.

7. Fertile participants who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures).

8. Previous treatment with SVF.

9. Conditions/therapies/factors which could confound or interfere with the evaluation of pain including but not limited to:
a) Treatments with strong opioid drugs in the previous 60 days for pain
b) Procedures planned during the study period which could interfere with pain assessment (e.g. surgery)
c) Other causes of chronic pain (e.g. neck pain)

10. Use of anticoagulant medication
11. Consistent use of NSAIDs within 48 hours of procedure.
12. Aspirin (except at low dose for cardioprotection), Vitamin E, Fish Oil, krill oil or anti-inflammatories for one week prior
13. Insufficient fat present for liposuction.
14. Inability to understand the study or complete headache diary/ SF-36 questionnaires.
15. Allergic to dimethyl sulfoxide (DMSO)
16. Inability to provide informed consent

Contact details and further information

Primary Sponsor

Type: Commercial sector/Industry
Name: Cell-Innovations
Address: PO Box 7342
WARRINGAH NSW 2100
Country: Australia

Contact person for information and recruitment

Ms Jane Young
Cell-Innovations
PO Box 7342
WARRINGAH NSW 2100
Australia
+61 1300 738 025
trials@cell-innovations.com.au