MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer (NCT04489732) | Clinical Trial Compass
Active — Not RecruitingPhase 1
MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer
United States6 participantsStarted 2022-02-18
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 …
What they're measuring
1
Percentage of Subjects Experiencing Dose Limiting Toxicity (DLT)
Timeframe: up to 1 month post injection (up to 3 months from consent)