Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392711
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-25
Brief Title:
Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
UW23129 A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells MSCs into salivary glands The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth
Participants will
have bone marrow collected using a needle
undergo a salivary gland ultrasound
complete questionnaires
receive an injection of the bone marrow cells into a salivary gland
Participants will
have bone marrow collected using a needle
undergo a salivary gland ultrasound
complete questionnaires
receive an injection of the bone marrow cells into a salivary gland
Detailed Description:
This single-center phase I dose-escalation with expansion cohort open label non-randomized non-placebo controlled single group assignment study will assess the safety and tolerability of mesenchymal stromal cells MSCs for treatment of xerostomia focusing on xerostomia with inflammatory etiology eg Sjögrens disease SjD graft-versus-host disease GVHD An initial cohort of subjects n6 will receive a unilateral injection of MSCs at dose level 0 If unilateral treatment is tolerated a dose escalation cohort n8-18 will receive bilateral injection of MSCs Dose escalation will proceed using a standard 33 design and once the recommended phase II dose RP2D is defined 12 additional patients will be accrued to the expansion phase
Following the completion of screeningbaseline procedures eligible participants will undergo bone marrow aspiration in order to obtain MSCs
The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit
Following the completion of screeningbaseline procedures eligible participants will undergo bone marrow aspiration in order to obtain MSCs
The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A534290 | OTHER | None | None |
| SMPHMEDICINERHEUMATOL | OTHER | None | None |
| UW23129 | OTHER | None | None |
| Protocol Version 122023 | OTHER | UW- Madison | None |