Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer

2020-1290

This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enrolled and can expect to be on study for up to 2 years.

2022-02-18

2022-11-22

2024-05-01

Early phase I

6

Inclusion Criteria: * Willing to provide informed consent * Willing to comply with all study procedures and be available for the duration of the study * Histological diagnosis of Head and Neck Cancer (HNC) and ≥ 2 years from completion of treatment for HNC, either clinically or radiologically No Evidence of Disease (NED), as assessed by ENT or Radiation Oncologist within 28 days of study registration * Individuals at least 18 years of age and no older than 90 years of age * Xerostomia defined as less than or equal to 80 percent of baseline (pre-radiation) salivary function per patient estimate * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia * Radiographically confirmed bilateral submandibular glands * Females of childbearing potential must agree to have a negative urine or serum pregnancy test within 7 days prior to bone marrow biopsy. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Women of childbearing potential in sexual relationships with men must have used an acceptable method of contraception for 30 days prior to study registration and agree to use an acceptable method of contraception until 4 weeks after completing study treatment. Males must agree to avoid impregnation of women during and for four weeks after completing study treatment through use of an acceptable method of contraception. Note: Acceptable method of contraception includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy) Exclusion Criteria: * History of sialolithiasis * Patients with one submandibular gland * History of autoimmune diseases affecting salivary glands, including Sjögren's syndrome, lupus, scleroderma, type I diabetes, sarcoidosis, and amyloidosis * Chronic graft vs host disease * Untreated oral candidiasis * Use of anti-cholinergic medications (e.g. atropine, ipratropium, oxybutynin, scopolamine, solifenacin, tiotropium, etc...) while enrolled on study * Malignancy within the past 2 years, except adequately treated stage I lung cancer, low risk prostate cancer that has been treated or is undergoing active surveillance, adequately treated non-melanoma skin cancer, adequately treated ductal carcinoma in situ (DCIS), or adequately treated stage I cervical cancer * Expected life expectancy ≤ 6 months * Lidocaine allergy * Use of investigational drugs, biologics, or devices within 30 days prior to enrollment * Women who are pregnant, lactating or planning on becoming pregnant during the study * Not suitable for study participation due to other reasons at the discretion of the investigators

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-center, open-label, non-randomized, non-placebo controlled, single-group assignment, pilot study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2024-02-23