Stromal Vascular Fraction for Treatment of Xerostomia

NCT03061110 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: MZ2017003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Xerostomia Due to Radiotherapy (Disorder)

Outcome Measures

Primary Outcomes (1)

• Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines)

  Reported Adverse Events graded according to CTCAE guidelines will be recorded starting at or after the time of injection and at or before 72 hours post injection.

  72 hours

Secondary Outcomes (31)

• Chronic Safety Profile (Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines)

  Months 3, 6 and 12 after Day 0 (date of injection)

• Unstimulated Saliva Production

  Assessed at Baseline and 3 months, 6 months and 12 months after Baseline

• Stimulated Saliva Production

  Assessed at Baseline and 3 months, 6 months and 12 months after Baseline

• University of Rotterdam Hospital Xerostomia Questionnaire- "How severe is your dry mouth problem?"

  Assessed at Baseline and 3 months, 6 months and 12 months after Baseline

• University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air)

  Assessed at Baseline and 3 months, 6 months and 12 months after Baseline

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Stromal Vascular Fraction

EXPERIMENTAL

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

Biological: Stromal Vascular Fraction

Interventions

Stromal Vascular Fraction BIOLOGICAL

Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.

Also known as: Adipose-Derived Stem Cells

Stromal Vascular Fraction

Usual Care OTHER

Usual care will include over-the-counter and prescription methods to treat xerostomia.

Also known as: Standard of Care

Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwestern Regional Medical Center: lead

Study Sites (1)

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stephen Ray, MD

  Midwestern Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon

Model Details: Subjects will be randomly assigned to usual care (palliation of symptoms) or injection of stromal vascular fraction.

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: November 1, 2018
• Primary Completion: December 28, 2020
• Study Completion: December 31, 2020
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (1)