Stromal Vascular Fraction for Treatment of Xerostomia

Midwestern Regional Medical Center

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Xerostomia Due to Radiotherapy (Disorder)

Treatments: Biological: Stromal Vascular Fraction; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03061110

MZ2017003

Details and patient eligibility

About

Prospective, single center, double armed, randomized treatment with observation only (standard of care) control group. Subjects receiving study treatment will have 6 months of study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will be injected into salivary glands to determine safety and efficacy to restore saliva production in head and neck cancer patients with chronic xerostomia resulting from radiation therapy.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female subjects are both eligible
• Subjects must be 21 years of age or older
• History of treated Head and Neck Cancer, no evidence of active cancer at the time of the study
• Original tumor not located adjacent to the parotid or sub-mandibular glands
• Diagnosis of radiation-induced xerostomia
• study is fully explained
• Females of child bearing potential agree to use acceptable methods of contraception through 6 month study follow-up.
• No current malignancy or history of previous malignancy within the last five years, other than the head and neck cancer, with the exception of adequately treated non-abdominal, non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin)
• Willing to undergo a minor surgical procedure (small-volume liposuction, totaling approximately 60-120cc) and a single treatment of an injection of approximately 30ml of autologous Stromal Vascular Fraction taking approximately 10 minutes
• Abdominal area amenable to liposuction of at least 60-120cc of adipose tissue based on Investigator(s) examination
• Willing to be available for all baseline, treatment and follow-up examinations required by protocol
• Willing to forego participation in any other study throughout the duration of this study unless receiving prior approval by Investigator

Exclusion criteria

• Patients taking immunosuppressive therapy in the prior 3 months
• Autoimmune disorders
• Patients who are pregnant or currently breast-feeding children
• Patients participating in a study of an experimental drug or medical device within 60 days of study entry
• Uncontrolled hypertension
• Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening
• Hemoglobin A1c > 8% within 8 weeks prior to study treatment
• Current use of steroids or immunosuppressant therapies
• Any other condition, which, in the opinion of the Investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results
• History of Sjogren's Syndrome or related autoimmune disease.
• Taking medication for which xerostomia is a known major side effect

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Subjects in the Usual Care arm will receive typical therapies to manage the symptoms of dry mouth including but not limited to: chewing gum, sucking sugar-free candy, sipping water, mouth rinses and over-the-counter artificial saliva preparations.

Treatment:

Other: Usual Care

Stromal Vascular Fraction

Experimental group

Description:

Subjects in the Stromal Vascular Fraction arm will receive single injections into each of the six (6) peri-oral salivary glands (parotid, submandibular, sublingual).

Treatment:

Biological: Stromal Vascular Fraction