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:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkimple@humonc.wisc.edu', 'phone': '608-263-5361', 'title': 'Randy Kimple, MD, PhD, FASTRO', 'organization': 'University of Wisconsin Carbone Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Toxicities regardless of attribution were recorded through the 3 month post injection visit per protocol (up to 5 months from participant consent) for primary outcomes.', 'description': 'Follow up for serious adverse events continues through 24 months post injection (up to 26 months from participant consent).', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment With MSCs', 'description': 'A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia\n\nAutologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells: Single dose, starting at\n\n* Dose Level 0: 10 x 10\\^6 injected into one submandibular gland on Day 1', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site reaction (pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaccine site lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphocyte decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Bone pain (bone marrow aspiration)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet Count Decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cardiac Troponin 1 increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Experiencing Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With MSCs', 'description': 'A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia\n\nAutologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells: Single dose, starting at\n\n* Dose Level 0: 10 x 10\\^6 injected into one submandibular gland on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 month post injection (up to 3 months from consent)', 'description': 'Dose limiting toxicity is defined as: submandibular pain \\> 5 on a pain scale of 0-10 at 1-month after MSC injection OR any serious AE OR any of the selected toxicities listed per protocol within one-month post-injection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Saliva Production Rate', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Saliva Composition Analysis: Change in Salivary pH', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Saliva Composition Analysis: Change in Total Protein Concentration in Saliva', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Saliva Composition Analysis: Change in Amylase Concentration in Saliva', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Saliva Composition Analysis: Change in Mucin Concentration in Saliva', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) Score', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in The MD Anderson Dysphagia Index (MDADI) Score', 'timeFrame': 'baseline(up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analogue Scale (VAS) Xerostomia Score', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Salivary Gland Size', 'timeFrame': 'baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection', 'description': 'Salivary gland size measured by ultrasound imaging', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Salivary Gland Stiffness Measured by Shear Wave Velocity', 'timeFrame': 'baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection', 'description': 'Salivary gland stiffness (fibrosis) will be measured by acoustic radiation force impulse imaging. Evaluators will be blinded to the time point of evaluation (pre- or post- MSC injection)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Participant Drop Out Rate', 'timeFrame': 'up to 24 months post-injection (up to 26 months from consent)', 'description': 'Study feasibility will in part be measured by participant drop out rate.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With MSCs', 'description': 'A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia\n\nAutologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells: Single dose, starting at\n\n* Dose Level 0: 10 x 10\\^6 injected into one submandibular gland on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at the UW Hospital and Clinics from February 2022 to September 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With MSCs', 'description': 'A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia\n\nAutologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells: Single dose, starting at\n\n* Dose Level 0: 10 x 10\\^6 injected into one submandibular gland on Day 1'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '60-69 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-28', 'size': 2664675, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-21T11:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-center, open-label, non-randomized, non-placebo controlled, single-group assignment, pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2020-07-23', 'resultsFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-21', 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Experiencing Dose Limiting Toxicity (DLT)', 'timeFrame': 'up to 1 month post injection (up to 3 months from consent)', 'description': 'Dose limiting toxicity is defined as: submandibular pain \\> 5 on a pain scale of 0-10 at 1-month after MSC injection OR any serious AE OR any of the selected toxicities listed per protocol within one-month post-injection.'}], 'secondaryOutcomes': [{'measure': 'Change in Saliva Production Rate', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.'}, {'measure': 'Saliva Composition Analysis: Change in Salivary pH', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .'}, {'measure': 'Saliva Composition Analysis: Change in Total Protein Concentration in Saliva', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.'}, {'measure': 'Saliva Composition Analysis: Change in Amylase Concentration in Saliva', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.'}, {'measure': 'Saliva Composition Analysis: Change in Mucin Concentration in Saliva', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.'}, {'measure': 'Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) Score', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.'}, {'measure': 'Change in The MD Anderson Dysphagia Index (MDADI) Score', 'timeFrame': 'baseline(up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.'}, {'measure': 'Change in Visual Analogue Scale (VAS) Xerostomia Score', 'timeFrame': 'baseline (up to 8 weeks before injection), 1, 3, 6, 12, and 24 months post-injection', 'description': 'A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms'}, {'measure': 'Change in Salivary Gland Size', 'timeFrame': 'baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection', 'description': 'Salivary gland size measured by ultrasound imaging'}, {'measure': 'Change in Salivary Gland Stiffness Measured by Shear Wave Velocity', 'timeFrame': 'baseline (up to 8 weeks before injection), 3, 6, and 12 months post-injection', 'description': 'Salivary gland stiffness (fibrosis) will be measured by acoustic radiation force impulse imaging. Evaluators will be blinded to the time point of evaluation (pre- or post- MSC injection)'}, {'measure': 'Participant Drop Out Rate', 'timeFrame': 'up to 24 months post-injection (up to 26 months from consent)', 'description': 'Study feasibility will in part be measured by participant drop out rate.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Xerostomia Following Radiotherapy']}, 'referencesModule': {'references': [{'pmid': '37589639', 'type': 'DERIVED', 'citation': 'Blitzer GC, Glazer T, Burr A, Gustafson S, Ganz O, Meyers R, McDowell KA, Nickel KP, Mattison RJ, Weiss M, Chappell R, Rogus-Pulia NM, Galipeau J, Kimple RJ. Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction (MARSH): A pilot, first-in-human study of interferon gamma-stimulated marrow mesenchymal stromal cells for treatment of radiation-induced xerostomia. Cytotherapy. 2023 Nov;25(11):1139-1144. doi: 10.1016/j.jcyt.2023.07.009. Epub 2023 Aug 15.'}, {'pmid': '35183442', 'type': 'DERIVED', 'citation': 'Blitzer GC, Rogus-Pulia NM, Mattison RJ, Varghese T, Ganz O, Chappell R, Galipeau J, McDowell KA, Meyers RO, Glazer TA, Kimple RJ. Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction (MARSH): Study protocol for a phase 1 dose-escalation trial of patients with xerostomia after radiation therapy for head and neck cancer: MARSH: Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction. Cytotherapy. 2022 May;24(5):534-543. doi: 10.1016/j.jcyt.2021.11.003. Epub 2022 Feb 16.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Following the completion of screening/baseline procedures, and written consent, eligible participants will undergo bone marrow aspirate in order to obtain MSCs.\n\nThe 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.\n\nAll 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.\n\nDose Reduction:\n\n* 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.\n* If DLT in greater than 1 participant, dose level -1 will be administered, staggered at least 14 days in n=6 participants.\n* 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.\n\nPrimary Objective\n\n* To evaluate the safety and tolerability of MSCs for subjects with xerostomia after radiation therapy for HNC.\n\nSecondary Objectives\n\n* 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.\n* To assess the imaging characteristics in HNC patients after MSC injection using ultrasound.\n* To assess the feasibility of a future Phase 1 dose-escalation study.\n\nPer 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing to provide informed consent\n* Willing to comply with all study procedures and be available for the duration of the study\n* 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\n* Individuals at least 18 years of age and no older than 90 years of age\n* Xerostomia defined as less than or equal to 80 percent of baseline (pre-radiation) salivary function per patient estimate\n* Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia\n* Radiographically confirmed bilateral submandibular glands\n* 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:\n\n * has not undergone a hysterectomy or bilateral oophorectomy; or\n * 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)\n* 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.\n\nNote: 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)\n\nExclusion Criteria:\n\n* History of sialolithiasis\n* Patients with one submandibular gland\n* History of autoimmune diseases affecting salivary glands, including Sjögren's syndrome, lupus, scleroderma, type I diabetes, sarcoidosis, and amyloidosis\n* Chronic graft vs host disease\n* Untreated oral candidiasis\n* Use of anti-cholinergic medications (e.g. atropine, ipratropium, oxybutynin, scopolamine, solifenacin, tiotropium, etc…) while enrolled on study\n* 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\n* Expected life expectancy ≤ 6 months\n* Lidocaine allergy\n* Use of investigational drugs, biologics, or devices within 30 days prior to enrollment\n* Women who are pregnant, lactating or planning on becoming pregnant during the study\n* Not suitable for study participation due to other reasons at the discretion of the investigators"}, 'identificationModule': {'nctId': 'NCT04489732', 'briefTitle': 'MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Pilot Study of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer', 'orgStudyIdInfo': {'id': '2020-1290'}, 'secondaryIdInfos': [{'id': 'A533300', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/HUMAN ONCOLOGY/HUMAN ONCO', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'UW20025', 'type': 'OTHER', 'domain': 'UWCCC'}, {'id': 'NCI-2021-00070', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}, {'id': '1UG3DE030431-01', 'link': 'https://reporter.nih.gov/quickSearch/1UG3DE030431-01', 'type': 'NIH'}, {'id': 'Protocol Version 9/28/2023', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Head & Neck SPORE', 'type': 'OTHER', 'domain': 'Dr. Jacques Galipeau, MD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with MSCs', 'description': "A single dose of MSCs injected into the submandibular glands of patients with radiation-induced xerostomia (primary objective)\n\nFollowing primary outcomes, a second injection of 10 (8 - 12) x 106 MSCs will be offered for injection into each participant's contralateral submandibular gland.", 'interventionNames': ['Biological: Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells']}], 'interventions': [{'name': 'Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells', 'type': 'BIOLOGICAL', 'description': "Single dose, starting at\n\n* Dose Level 0: 10 (8-12) x 10\\^6 injected into one submandibular gland on Day 1\n\nSub-study for second injection after primary objectives met, 10 (8 - 12) x 10\\^6 MSCs will be offered for injection into each participant's contralateral submandibular gland", 'armGroupLabels': ['Treatment with MSCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Randall J Kimple, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Jacques Galipeau, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}