Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04489732
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2020-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Following the completion of screening/baseline procedures, and written consent, eligible participants will undergo bone marrow aspirate in order to obtain MSCs.
The MSC Investigational Medicinal Product (IMP) (dose level 0, n=6, staggered) will be injected into one submandibular gland under local anesthesia, in the gland that received the lowest radiation dose. Patients with only one submandibular gland will be ineligible.
All participants will be called by a study coordinator 3 days (+/- 2 days) after injection to assess pain and will have a phone visit with a physician 1 week (+/- 2 days) after injection during which the investigator will assess pain and ask about the area of injection regarding redness and/or swelling. All participants will complete a pain diary with daily entries over the first month to record the occurrence and severity of pain using a 0-10 visual analog scale and occurrence and severity of other adverse events (e.g., redness, swelling, warmth, tenderness, rash, pruritis, nausea, vomiting, fatigue). Participants will also keep a log of all pain medications taken including both narcotic and non-narcotic medications (e.g. ibuprofen, acetaminophen, etc.) for the first month. Participants will complete 5 follow-up visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the intervention. Salivary collection for analysis as well as QoL surveys will be obtained at these visits.
Dose Reduction:
* If dose limiting toxicity (DLT) in less than or equal to 1 participant (n=6 participants, staggered at least 14 days), Dose Level 0 will be recommended as starting dose for subsequent trial.
* If DLT in greater than 1 participant, dose level -1 will be administered, staggered at least 14 days in n=6 participants.
* If DLT in this cohort is in less than or equal to 1 participant, Dose Level -1 will be recommended as starting dose for subsequent trial. If DLT in greater than or equal to 2 participants, study will be stopped.
Primary Objective
* To evaluate the safety and tolerability of MSCs for subjects with xerostomia after radiation therapy for HNC.
Secondary Objectives
* To evaluate the efficacy of MSCs for treatment of xerostomia and salivary hypofunction via quality-of-life (QoL) questionnaires, salivary amount, and salivary compositional analysis.
* To assess the imaging characteristics in HNC patients after MSC injection using ultrasound.
* To assess the feasibility of a future Phase 1 dose-escalation study.
Per Amendment Approved 4/14/23: Sub-study added, all enrolled participants will be offered injection of MSCs into the contralateral submandibular gland upon completion of the trial's primary objective (1 month of follow-up after injection of MSCs without any DLTs). The MSC IMP will be injected into the contralateral submandibular gland under local anesthesia.
Participants will complete 5 follow-up visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the contralateral injection. Salivary collection for analysis as well as QoL surveys will be obtained at all visits, except the 24 month follow-up visit.
The MSC Investigational Medicinal Product (IMP) (dose level 0, n=6, staggered) will be injected into one submandibular gland under local anesthesia, in the gland that received the lowest radiation dose. Patients with only one submandibular gland will be ineligible.
All participants will be called by a study coordinator 3 days (+/- 2 days) after injection to assess pain and will have a phone visit with a physician 1 week (+/- 2 days) after injection during which the investigator will assess pain and ask about the area of injection regarding redness and/or swelling. All participants will complete a pain diary with daily entries over the first month to record the occurrence and severity of pain using a 0-10 visual analog scale and occurrence and severity of other adverse events (e.g., redness, swelling, warmth, tenderness, rash, pruritis, nausea, vomiting, fatigue). Participants will also keep a log of all pain medications taken including both narcotic and non-narcotic medications (e.g. ibuprofen, acetaminophen, etc.) for the first month. Participants will complete 5 follow-up visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the intervention. Salivary collection for analysis as well as QoL surveys will be obtained at these visits.
Dose Reduction:
* If dose limiting toxicity (DLT) in less than or equal to 1 participant (n=6 participants, staggered at least 14 days), Dose Level 0 will be recommended as starting dose for subsequent trial.
* If DLT in greater than 1 participant, dose level -1 will be administered, staggered at least 14 days in n=6 participants.
* If DLT in this cohort is in less than or equal to 1 participant, Dose Level -1 will be recommended as starting dose for subsequent trial. If DLT in greater than or equal to 2 participants, study will be stopped.
Primary Objective
* To evaluate the safety and tolerability of MSCs for subjects with xerostomia after radiation therapy for HNC.
Secondary Objectives
* To evaluate the efficacy of MSCs for treatment of xerostomia and salivary hypofunction via quality-of-life (QoL) questionnaires, salivary amount, and salivary compositional analysis.
* To assess the imaging characteristics in HNC patients after MSC injection using ultrasound.
* To assess the feasibility of a future Phase 1 dose-escalation study.
Per Amendment Approved 4/14/23: Sub-study added, all enrolled participants will be offered injection of MSCs into the contralateral submandibular gland upon completion of the trial's primary objective (1 month of follow-up after injection of MSCs without any DLTs). The MSC IMP will be injected into the contralateral submandibular gland under local anesthesia.
Participants will complete 5 follow-up visits over the course of 24 months - at 1, 3, 6, 12, and 24 months following the contralateral injection. Salivary collection for analysis as well as QoL surveys will be obtained at all visits, except the 24 month follow-up visit.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| A533300 | OTHER | UW Madison | View | |
| SMPH/HUMAN ONCOLOGY/HUMAN ONCO | OTHER | UW Madison | View | |
| UW20025 | OTHER | UWCCC | View | |
| NCI-2021-00070 | REGISTRY | NCI CTRP | View | |
| 1UG3DE030431-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| Protocol Version 9/28/2023 | OTHER | UW Madison | View | |
| Head & Neck SPORE | OTHER | Dr. Jacques Galipeau, MD | View |