Mesenchymal Stromal Cells for Dry Mouth
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Wisconsin, Madison
Must not be taking: Diuretics, Investigational drugs
Disqualifiers: Diabetes, Malignancy, Transfusion dependency, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, you must be on a stable dose for at least 2 months.
What data supports the effectiveness of the treatment Mesenchymal Stromal Cells for Dry Mouth?
Research suggests that adipose-derived mesenchymal stem cells (a type of cell that can develop into different types of tissues) have shown potential in restoring salivary gland function in patients who have undergone radiation therapy for head and neck cancer, which often causes dry mouth.
12345Are mesenchymal stromal cells safe for use in humans?
Research indicates that mesenchymal stromal cells (MSCs) are generally safe in humans, with transient fever being the most common treatment-related side effect. They have fewer safety concerns compared to embryonic stem cells.
16789How is the treatment with Mesenchymal Stromal Cells for dry mouth different from other treatments?
Mesenchymal Stromal Cells (MSCs) are unique because they are adult stem cells capable of transforming into various cell types, which can help regenerate tissues. This regenerative ability makes them different from standard treatments, as they offer a novel approach to potentially repair and restore function in tissues affected by dry mouth.
110111213Eligibility Criteria
This trial is for individuals with dry mouth due to conditions like Graft-versus-Host Disease or Sjögren's Syndrome. Participants will have bone marrow collected, undergo an ultrasound of their salivary glands, fill out questionnaires, and receive an injection of their own bone marrow cells into a salivary gland.Inclusion Criteria
Willing and able to give informed consent
I am willing to use birth control during the study.
I am between 18 and 90 years old.
+6 more
Exclusion Criteria
Life expectancy ≤ 6 months as determined by the investigator
My diabetes is not well-managed (HBA1c is 7% or higher).
I have been diagnosed with cancer in the last 2 years.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline
Participants undergo bone marrow aspiration and salivary gland ultrasound
1 week
1 visit (in-person)
Treatment
Participants receive MSC injections into one or both submandibular glands
1 day
1 visit (in-person)
Dose Escalation
Dose escalation cohort receives MSC injections at increasing doses
Varies
Expansion
Expansion cohort receives MSC injections at the recommended phase II dose
Varies
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Multiple visits (in-person and virtual)
Participant Groups
The trial is testing the safety and potential benefits of injecting mesenchymal stromal cells (MSCs) at two different dose levels directly into the salivary glands to see if it can improve symptoms of dry mouth in patients.
3Treatment groups
Active Control
Group I: MSCs Dose Level 0 into one submandibular glandActive Control1 Intervention
6 subjects will receive Mesenchymal Stromal Cells (MSC) at Dose Level 0, which is 10 (8-12) x10\^6 MSCs in a single submandibular gland. If this dose is deemed tolerable when injected into a single submandibular gland, this dose will be administered to both submandibular glands in the initial subjects in the dose escalation arm.
Group II: MSCs into both submandibular glands - Dose Escalation CohortActive Control2 Interventions
8-18 subjects in the Dose Escalation phase of study will receive MSCs into both submandibular glands. The initial subjects in this cohort will receive Dose Level 0: 10 (8-12) x10\^6 MSCs/gland. If this dose is tolerated, subsequent subjects will receive Dose Level 1: 20 (16-24) x10\^6 MSCs/gland. The highest tolerated dose (recommended phase II dose or RP2D) will be administered to the subjects in the Expansion Cohort.
Group III: MSCs into both submandibular glands - Expansion CohortActive Control2 Interventions
12 subjects in Expansion Cohort will receive MSCs into both submandibular glands at the RP2D.
Mesenchymal Stromal Cells is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Mesenchymal Stromal Cells for:
- Graft-versus-host disease (GVHD)
- Autoimmune diseases
🇺🇸 Approved in United States as Mesenchymal Stromal Cells for:
- Graft-versus-host disease (GVHD)
- Pediatric steroid-refractory GVHD
🇨🇦 Approved in Canada as Mesenchymal Stromal Cells for:
- Pediatric steroid-refractory GVHD
🇯🇵 Approved in Japan as Mesenchymal Stromal Cells for:
- Pediatric steroid-refractory GVHD
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WisconsinMadison, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
References
Differential properties of human stromal cells from bone marrow, adipose, liver and cardiac tissues. [2018]Mesenchymal stromal cells (MSCs), derived from several tissues including bone marrow and adipose tissue, are being evaluated in clinical trials for a range of diseases. Virtually all tissues of the body contain stromal cells, yet it is unknown whether these sources are similar in phenotype and function.
Intraglandular mesenchymal stem cell treatment induces changes in the salivary proteome of irradiated patients. [2022]Hyposalivation and xerostomia (dry mouth), are the leading site-effects to treatment of head and neck cancer. Currently, there are no effective therapies to alleviate radiation-induced hyposalivation. Adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) have shown potential for restoring salivary gland function. However, the mode of action is unknown. The purpose of the present study was therefore to characterize the effect of AT-MSC therapy on the salivary proteome in previously irradiated head and neck cancer patients.
Enhancement of fat graft survival by bone marrow-derived mesenchymal stem cell therapy. [2021]Adipose-derived stem cells can improve fat graft survival, but there is no literature reporting whether bone marrow-derived mesenchymal stem cells enhance fat graft survival. The authors explored the feasibility of enhancing fat graft survival using bone marrow-derived mesenchymal stem cells.
Systemic transplantation of human adipose tissue-derived mesenchymal stem cells for the regeneration of irradiation-induced salivary gland damage. [2021]Cell-based therapy has been reported to repair or restore damaged salivary gland (SG) tissue after irradiation. This study was aimed at determining whether systemic administration of human adipose-derived mesenchymal stem cells (hAdMSCs) can ameliorate radiation-induced SG damage.
Studies in adipose-derived stromal cells: migration and participation in repair of cranial injury after systemic injection. [2021]Adipose-derived stromal cells are a multipotent cell type with the ability to undergo osteogenic differentiation. The authors sought to examine whether systemically administered adipose-derived stromal cells would migrate to and heal surgically created defects of the mouse cranial skeleton.
Transient Fever: the Sole Treatment-Related Adverse Event associated with Mesenchymal Stromal Cells and Solid Clues from the Real World. [2023]The number of trials investigating mesenchymal stromal cells (MSCs) soars within 3 years which urges a study analysing emerging MSC treatment-related adverse events.
The developmental basis of mesenchymal stem/stromal cells (MSCs). [2023]Mesenchymal Stem/Stromal Cells (MSCs) define a population of progenitor cells capable of giving rises to at least three mesodermal lineages in vitro, the chondrocytes, osteoblasts and adipocytes. The validity of MSCs in vivo has been questioned because their existence, either as a homogeneous progenitor cell population or as a stem cell lineage, has been difficult to prove. The wide use of primary MSCs in regenerative and therapeutic applications raises ethical and regulatory concerns in many countries. In contrast to hematopoietic stem cells, a parallel concept which carries an embryological emphasis from its outset, MSCs have attracted little interest among developmental biologists and the embryological basis for their existence, or lack thereof, has not been carefully evaluated.
Mesenchymal stromal cells: past, present, and future. [2022]Adult mesenchymal stromal cells are plastic-adherent cells that are self-renewing and have the capacity to differentiate into various tissue specific lineages. Stromal cells were initially discovered over 100 years ago and substantial insight into stromal cell identification, isolation, characterization, and differentiation has been made, including efforts to elucidate the factors involved in stromal cell differentiation. Stromal cells have immune privilege and thus are attractive candidates for tissue engineering and regenerative medicine applications. Positive results from a number of recent investigations support the use of adult mesenchymal stromal cells for clinical application. This review article provides a brief overview of past, present, and future stromal cell technology.
Emerging Role of Oral Mesenchymal Stem/Stromal Cells and Their Derivates. [2023]Mesenchymal stem/stromal cells (MSCs) have fewer ethical, moral, and safety problems in comparison with embryonic stem cells [...].
The role of dental stem cells in regeneration. [2020]Mesenchymal stem cells (MSCs) are adult stem cells that have the capacity of rising multiple cell types. A rich source of mesenchymal stem cells is represented by the dental tissues: the periodontal ligament, the dental pulp, the apical papilla, the dental follicle and the deciduous teeth. The aim of this review is to characterize the main dental- derived mesenchymal stem cell population, and to show their important role in tissue regeneration based on their properties : the multi-potency, the high proliferation rate, the differentiation in multiple cell lineages, the high cell viability and the positive expression for mesenchymal cell markers. Tissue regeneration or de novo' formation of craniofacial structures is the future of regenerative medicine, offering a solution for congenital malformations, traumas and other diseases.
Dental stem cells--characteristics and potential. [2022]Soft dental tissues have been identified as easily accessible sources of multipotent postnatal stem cells. Dental stem cells are mesenchymal stem cells (MSC) capable of differentiating into at least three distinct cell lineages: osteo/odontogenic, adipogenic and neurogenic. They express various markers including those specific for MSC, embryonic stem cells and neural cells. Five different types of dental stem cells have been isolated from mature and immature teeth: dental pulp stem cells, stem cells from exfoliated deciduous teeth, periodontal ligament stem cells, stem cells from apical papilla and dental follicle progenitor cells. Dental stem cells may be used in dental tissue engineering including dental, enamel and periodontal tissue regeneration. They could also be used as a promising tool in potential treatment of neurodegenerative, ischemic and immune diseases.
Phenotypic characterizations and comparison of adult dental stem cells with adipose-derived stem cells. [2022]Mesenchymal stem cells or "multipotent stromal cells" are heterogeneous cell population with self-renewal and multilinage differentiation. The aim of this study was to examine and compare the expression of important stem cell surface markers on two populations of mesenchymal stem cells, one derived from human exfoliated deciduous teeth and the other derived from human adipose tissue. These new stem cells will offer a promising avenue for prevention and reversal of many human diseases such as type 1 diabetes and prevention of liver fibrotic process.
Effects of demineralized bone matrix on proliferation and osteogenic differentiation of mesenchymal stem cells from human umbilical cord. [2018]Mesenchymal stem cells or mesenchymal progenitor cells are defined as self-renewable, multipotent progenitor cells with the unlimited capacity to differentiate into multiple lineage-specific cells that form bone, cartilage, fat, and muscle tissues. Demineralized bone matrix (DBM) has been extensively utilized in orthopaedic, periodontal, and maxillofacial applications and widely investigated as a biomaterial to promote new bone formation.