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Irradiation-Induced Parotid Salivary Hypofunction - Healing Genes
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Irradiation-Induced Parotid Salivary Hypofunction

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Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction

Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of an Adeno-Associated Virus Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals With Irradiation-Induced Parotid Salivary Hypofunction


Phase 1 / 2

DESCRIPTION:

Doctors at the National Institutes of Health Clinical Center seek participants to trial a treatment for a common side effect of head and neck cancer radiation treatment, salivary gland damage leading to dry mouth and dental disorders. The treatment utilizes a viral transfer method to impart a  human aquaporin-1 (hAQP1) cDNA gene to parotid glands of adult patients with IR-induced salivary dysfunction. They hope this treatment will result in restored salivary output.

The treatment requires 2 screening visits, a 3-day hospital stay, and follow up including 10 visits over 3 years.


PATIENT MUST:

  • Be 18 years of age and older
  • History of radiation therapy for head and neck cancer
  • Abnormal parotid gland function
  • Must be willing to utilize acceptable birth control methods for a period of time

THE STUDY INVOLVES:

  1. Participants will be screened in 2 visits with:
    • medical history
    • physical exam
    • scans
    • saliva collections
    • A substance is injected in the parotid gland and X-rays are taken.
    • non-drug infusion
    • IV dose of glycopyrrolate to stop saliva
  2. 3-day hospital stay: Participants will get the gene infusion pushed through an opening into the gland inside the mouth.
  3. Follow up: 10 outpatient visits over 3 years. These may include:
    • repeats of screening tests
    • blood and urine tests
    • oral and head and neck exams, including a thin scope in the airway
    • questionnaires
    • small piece of skin taken
    • small piece of parotid tissue
    • Imaging scans
    • Participants will keep a diary about how they feel before and after the therapy.
    • oral microbiome gingival and buccal swab

LOCATIONS & CONTACTS:
The trial will take place at the National Institutes of Health Clinical Center in Bethesda, MD. Map.
 
Contact:
Katherine Hall, R.N., MSN  |  301-402-6905  |  [email protected]
John A Chiorini, Ph.D.  |  (301) 496-4279  |  [email protected]
 
SPONSORS:
MeiraGTx UK II Ltd
National Institute of Dental and Craniofacial Research (NIDCR)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02446249

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