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
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.
- 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:
- Participants will be screened in 2 visits with:
- medical history
- physical exam
- 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
- 3-day hospital stay: Participants will get the gene infusion pushed through an opening into the gland inside the mouth.
- 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
- 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.
Katherine Hall, R.N., MSN | 301-402-6905 | [email protected]
John A Chiorini, Ph.D. | (301) 496-4279 | [email protected]
MeiraGTx UK II Ltd
National Institute of Dental and Craniofacial Research (NIDCR)
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