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Sections: Correlations,
Clinical Trials, and HPO
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| drug350 | Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells Wiki | 1.00 |
| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
This is a single center, non-randomized, Phase I dose escalation study to assess the safety and tolerability of a single dose of autologous, bone marrow-derived, interferon gamma-stimulated Mesenchymal Stromal Cells (MSCs) injected into the submandibular glands of patients with radiation-induced xerostomia (dry mouth) following treatment for head and neck cancer (HNC).
Description: Dose limiting toxicity is defined as 1) score > 5 on a standard pain scale of 1-10, or 2) any serious adverse event. The percentage of subjects experiencing DLT will be used to determine the maximum tolerated dose or maximum administered dose. That dose will be the recommended dose for a phase 2 trial (RP2D).
Measure: Percentage of subjects experiencing dose limiting toxicity (DLT) Time: Day 30 ± 10 daysDescription: Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.
Measure: Change in Saliva production rate Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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 salivary pH Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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 total protein concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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 amylase concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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: Saliva composition analysis: Change in mucin concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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 University of Michigan Xerostomia Related Quality of Life (XeQOL) score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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 The MD Anderson Dysphagia Index (MDADI) score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: 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 Visual Analogue Scale (VAS) xerostomia score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: Salivary gland size measured by ultrasound imaging
Measure: Change in salivary gland size Time: at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports