Injecting bone marrow cells to treat dry mouth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of injecting mesenchymal stromal cells (MSCs) into the salivary glands of patients suffering from xerostomia, particularly due to conditions like Sjögren's disease and graft-versus-host disease. Participants will undergo bone marrow aspiration to collect MSCs, followed by ultrasound of the salivary glands and questionnaires. The study employs a dose-escalation design, starting with unilateral injections and potentially progressing to bilateral injections based on initial tolerability. The goal is to determine if these injections can improve dry mouth symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Xerostomia, defined as an unstimulated salivary flow \<1.2 mL in 5 minutes documented at any time following xerostomia diagnosis and prior to enrollment
* Xerostomia not resulting from radiotherapy (medical xerostomia)
* ≥ 18 years of age, ≤ 90 years of age
* Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia
* Willing and able to give informed consent
* Radiographically confirmed bilateral submandibular glands
* If female of childbearing potential, negative pregnancy test
* Males and females of childbearing potential willing to use acceptable contraception
* Laboratory Values (within 28 calendar days of enrollment):

  * Hgb ≥ 9 g/dL (5.58 mmol/L)
  * Platelets ≥ 100,000/µL
  * ANC ≥ 1000/µL
  * Lymphocytes ≥ 800/µL
  * PT/INR and PTT within normal limits based on age/sex

Exclusion Criteria:

* Patients with one submandibular gland
* Sialolithiasis
* Poorly-controlled diabetes mellitus (HbA1c ≥ 7%)
* Patients who initiated any diuretic therapy before developing dry mouth symptoms and are still on diuretic therapy and the referring provider believes the dryness symptoms are driven by diuretic use
* Untreated oral candidiasis based on physical exam at enrollment
* Malignancy within the last 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 DCIS, or adequately treated stage I cervical cancer)
* For patients on immunosuppressive therapy, must be on stable dose of immunosuppressive therapy for at least 2 months, allowing for dose adjustments for blood levels of drugs
* Transfusion dependency
* Life expectancy ≤ 6 months as determined by the investigator
* Use of investigational drugs, biologics, or devices within 30 calendar days prior to enrollment
* Pregnant or lactating women or those who plan to become pregnant during the study
* Not suitable for study participation due to other reasons at discretion of investigators.
* Enrollment in another clinical study possibly interfering with the endpoints of this study

Where it's running

• University of Wisconsin
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Zhubin Gahvari, MD, MS — University of Wisconsin, Madison
• Study coordinator: Cancer Connect
• Email: clinicaltrials@cancer.wisc.edu
• Phone: 800-622-8922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.