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Stromal Vascular Fraction for Treatment of Xerostomia

Primary Purpose

Xerostomia Due to Radiotherapy (Disorder)

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Stromal Vascular Fraction

Usual Care

About this trial

This is an interventional treatment trial for Xerostomia Due to Radiotherapy (Disorder)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Midwestern Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Stromal Vascular Fraction

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be recorded starting on Day 0 (day of SVF injection) and ending at 12 months.

Unstimulated Saliva Production

Rate of saliva production over a 5-minute period. (g/minute)

Stimulated Saliva Production

Rate of saliva production while chewing gum over a 5-minute period. (g/minute)

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

Mean score calculated from patient-reported survey (Likert Scale; 1 = Normal; 2 = somewhat more complaints than before radiation therapy; 3 = considerable more complaints than before radiation therapy; and 4 = Permanent complaints of a very dry mouth)

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

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

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)

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

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

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth during daytime)

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially dry mouth at nighttime)

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Always dry mouth night and day)

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

University of Rotterdam Hospital Xerostomia Questionnaire - "Under which circumstances does the dry mouth problem occur? (Especially bother of the dry mouth during meals)

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

University of Rotterdam Hospital Xerostomia Questionnaire- "How often do you wake up at night because of a dry mouth?"

Number of events as reported by patient (Number)

University of Rotterdam Hospital Xerostomia Questionnaire - "How would you describe the quality of your saliva?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = Normal, watery fluid; 2 = Normal watery but too little volume; 3 = Sticky saliva; and 4 = No saliva at all)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have difficulties with speech because of the dry mouth?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = No problems; unchanged with respect to situation before radiation therapy; 2 = Occasionally some difficulty with speech; 3 = Frequently speech problems; 4 = always difficulties with speech; and 5= always major speech problems)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate speech?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = Never; 2 = Occasionally; 3 = Frequently; 4 = Always; and 5= Even have to interrupt speaking to take a sip of water)

University of Rotterdam Hospital Xerostomia Questionnaire - "Is swallowing changed because of the dry mouth problem?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = No problems; unchanged with respect to situation before radiation therapy; 2 = Occasionally some difficulty with swallowing; 3 = Frequently problems with swallowing; 4 = Always swallowing difficulties; and 5 = Swallowing is seriously impaired because of the dry mouth problem)

University of Rotterdam Hospital Xerostomia Questionnaire - "Has the dry mouth a negative influence on chewing?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = No change in chewing capability; 2 = Some difficulty with chewing; 3 = Frequently difficulties with chewing; 4 = Always difficulties with chewing; 5 = Chewing is seriously hampered because of the dry mouth problem)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to sip water to facilitate eating?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = No never; 2 = Sometimes, depending on the quality of the food; 3 = Frequently; more often than before radiation therapy; and 4 = Always need to take a sip of water/ fluid with every bite of food)

University of Rotterdam Hospital Xerostomia Questionnaire - "Did you change your feeding habits?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = No change; 2 = Minor changes, such as avoiding some products; 3 = Can eat only mashed food; 4 = Can eat only liquid food; and 5= Tube feeding)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have painful, dry, or crusted lips?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = Never; 2 = Sometimes, depending on the weather and environmental circumstances; 3 = Frequently; and 4 = Always, day and night)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you need to carry a bottle of fluid with you when leaving home?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = Never 2 = Occasionally; 3 = Frequently; 4 = Very often; and 5 = Always)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you have a sore or painful mouth?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = Never 2 = Occasionally; 3 = Frequently; 4 = Very often; and 5 = Always)

University of Rotterdam Hospital Xerostomia Questionnaire - "Did your taste change?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = No change; normal taste sensation; 2 = Some reduction in taste discrimination and sensation; 3 = Considerable change in taste; 4 = No taste sensation at all; and 5 = Always a bad taste in the mouth)

University of Rotterdam Hospital Xerostomia Questionnaire - "Do you often have an infected oral mucosa or irritated gums?"

Incidence of each indication calculated from categorical patient-reported survey (Yes, No, Not Applicable)

University of Rotterdam Hospital Xerostomia Questionnaire - "Did your teeth deteriorate after radiation therapy?"

Mean score calculated from patient-reported survey (Likert Scale; 1 = never; 2 = Occasionally; 3 = Frequently; and 4 = Very often)

University of Rotterdam Hospital Xerostomia Questionnaire - Overall Xerostomia Index

Overall Xerostomia Index is calculated from the first three questions of the Questionnaire [I = (Q1 x 15.8) + (Q2 x 8.5) + (Q3 x 5.9) - 33.2; where Qn = score of that question.]

University of Michigan Xerostomia-Related Quality of Life Scale - Physical Functioning

Mean score calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)

University of Michigan Xerostomia-Related Quality of Life Scale - Pain/Discomfort

Mean score calculated from patient-reported survey (Likert Scale; 0=No Pain to 4=Worst Pain)

University of Michigan Xerostomia-Related Quality of Life Scale - Personal/Psychological Functioning

Mean score calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)

University of Michigan Xerostomia-Related Quality of Life Scale - Social Functioning

Mean score between Baseline and 3 months calculated from patient-reported survey (Likert Scale; 0=Best Functioning to 4=Worst Functioning)

Late Effects Normal Tissue-Subjective Objective Management Analytica (LENT-SOMA) survey

Mean score calculated from patient-reported survey (Likert Scale; 1=Best Functioning to 4=Worst Functioning)

Full Information

NCT ID

NCT03061110

First Posted

February 17, 2017

Last Updated

April 26, 2018

Sponsor

Midwestern Regional Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03061110

Brief Title

Stromal Vascular Fraction for Treatment of Xerostomia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Internal funding not awarded.

Study Start Date

November 1, 2018 (Anticipated)

Primary Completion Date

December 28, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Midwestern Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerostomia Due to Radiotherapy (Disorder)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Arm Title

Stromal Vascular Fraction

Arm Type

Experimental

Arm 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).

Intervention Type

Biological

Intervention Name(s)

Stromal Vascular Fraction

Other Intervention Name(s)

Adipose-Derived Stem Cells

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Usual Care

Other Intervention Name(s)

Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

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

Description

Reported Adverse Events graded according to Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be recorded starting on Day 0 (day of SVF injection) and ending at 12 months.

Time Frame

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

Title

Unstimulated Saliva Production

Description

Rate of saliva production over a 5-minute period. (g/minute)

Time Frame