Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System® ("Icellator") Autologous Adipose Stromal Vascular Fraction Cells as a Treatment for Post-Irradiated Induced Xerostomia in Head and Neck Cancer Patients

Stromal Vascular Fraction for Treatment of Xerostomia

Sponsors

Lead sponsor: Midwestern Regional Medical Center

Source Midwestern Regional Medical Center
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.

Overall Status Withdrawn
Start Date November 1, 2018
Completion Date December 31, 2020
Primary Completion Date December 28, 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Acute Safety Profile (Reported Adverse Events graded according to CTCAE guidelines) 72 hours
Secondary Outcome
Measure Time Frame
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
University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (In the open air in case of wind and cold) 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 air-conditioned spaces) 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? (Especially dry mouth during daytime) 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? (Especially dry mouth at nighttime) 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? (Always dry mouth night and day) 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? (Especially bother of the dry mouth during meals) Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire- "How often do you wake up at night because of a dry mouth?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "How would you describe the quality of your saliva?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate speech?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Is swallowing changed because of the dry mouth problem?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Has the dry mouth a negative influence on chewing?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate eating?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Did you change your feeding habits?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have painful, dry, or crusted lips?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to carry a bottle of fluid with you when leaving home?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have a sore or painful mouth?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Did your taste change?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Do you often have an infected oral mucosa or irritated gums?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - "Did your teeth deteriorate after radiation therapy?" Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Physical Functioning Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Pain/Discomfort Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Personal/Psychological Functioning Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
University of Michigan Xerostomia-Related Quality of Life Scale - Social Functioning Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Late Effects Normal Tissue-Subjective Objective Management Analytica (LENT-SOMA) survey Assessed at Baseline and 3 months, 6 months and 12 months after Baseline
Condition
Intervention

Intervention type: Biological

Intervention name: Stromal Vascular Fraction

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

Arm group label: Stromal Vascular Fraction

Other name: Adipose-Derived Stem Cells

Intervention type: Other

Intervention name: Usual Care

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

Arm group label: Usual Care

Other name: Standard of Care

Eligibility

Criteria:

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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Stephen Ray, MD Principal Investigator Midwestern Regional Medical Center
Location
facility Midwestern Regional Medical Center
Location Countries

United States

Verification Date

April 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Midwestern Regional Medical Center

Investigator full name: Stephen Ray, MD

Investigator title: Surgeon

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Usual Care

Arm group type: Active Comparator

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.

Arm group label: Stromal Vascular Fraction

Arm group type: Experimental

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).

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov