Trial Summary
What is the purpose of this trial?
The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to maintain your current treatment regimen for existing conservative therapy, like swallowing therapy.
What data supports the idea that Cell Therapy for Swallowing Disorders is an effective treatment?
The available research shows that cell therapy has been effective in other related conditions. For example, studies have shown that muscle-derived cells can help restore function in cases of urinary sphincter issues, which are similar in nature to swallowing disorders. Additionally, bone marrow-derived cells have been shown to aid in the regeneration of damaged intestinal tissue. These findings suggest that similar cell therapies could be effective for swallowing disorders by helping repair and regenerate the necessary muscle tissues.12345
What safety data exists for cell therapy in swallowing disorders?
The study titled 'Autologous Muscle-Derived Cell Therapy for Swallowing Impairment in Patients Following Treatment for Head and Neck Cancer' evaluates the safety and potential efficacy of autologous muscle-derived cells (AMDCs) for treating swallowing impairment. Additionally, the study 'Novel murine xenograft model for the evaluation of stem cell therapy for profound dysphagia' examines the safety and efficacy of human muscle-derived stem cell implantation in a mouse model. These studies provide some safety data for the use of muscle-derived cells in treating swallowing disorders.678910
Is the treatment AMDC-GIR a promising treatment for swallowing disorders?
Yes, AMDC-GIR is a promising treatment for swallowing disorders. It uses muscle-derived cells to help repair and improve swallowing function, which is important for people who have trouble swallowing, especially after treatments like those for head and neck cancer. This approach aims to restore the ability to swallow safely and effectively.236911
Eligibility Criteria
This trial is for adults who have moderate tongue dysphagia after treatment for oropharyngeal cancer and haven't improved with standard therapies. They must be at least 2 years post-treatment, disease-free, and able to report medical history. Excluded are those with recent participation in other trials, cell therapy for TD, certain health conditions like severe fibrosis or obesity, uncontrolled diabetes, bleeding disorders, allergies to specific drugs or proteins used in the study.Inclusion Criteria
I can eat solid foods without special preparation.
My symptoms did not improve after trying standard treatments.
I am over 18, had treatment for throat cancer over 2 years ago, and have trouble swallowing without cancer returning.
Exclusion Criteria
I need antibiotics regularly to prevent infections or have needed multiple antibiotic treatments recently.
Simultaneously participating in another investigational drug or device study or has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
I have not been part of a trial for TD treatment in the last 6 months.
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Treatment Details
Interventions
- Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (Cell Therapy)
Trial OverviewThe trial tests the safety of AMDC-GIR cells injected into patients' tongues to treat swallowing difficulties over a year. Participants have had surgery/chemo/radiotherapy for squamous cell carcinoma but still struggle with swallowing (tongue dysphagia) despite conventional treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 300 x 106 dosageExperimental Treatment1 Intervention
10 subjects will be receiving a dosage of 300 x 106 AMDC-GIR
Group II: 150 x 106 dosageExperimental Treatment1 Intervention
10 subjects will be receiving a dosage of 150 x 106 AMDC-GIR
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis Medical Center, Department of Otolaryngology, Head and Neck SurgerySacramento, CA
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Who Is Running the Clinical Trial?
Peter Belafsky, MDLead Sponsor
Cook MyoSiteIndustry Sponsor
References
Long-term repopulation effects of donor BMDCs on intestinal epithelium. [2021]Bone marrow-derived cells (BMDCs) have the ability to differentiate into intestinal epithelial cells after transplantation and participate in the regeneration process of damaged epithelium.
Present status and perspectives of stem cell-based therapies for gastrointestinal diseases. [2021]In recent years the interest in stem cell-based therapies for gastrointestinal injury has been increasing continuously. From the clinical point of view, transplantation of bone marrow derived stem cells may represent an alternative therapy for gastrointestinal injury, such as radioactive injury, inflammatory bowel disease, and other refractory gastrointestinal tract injury. There were several reports indicated that bone marrow derived stem cells located in the injured gastrointestinal tract and contributed to its regeneration by differentiating into functional epithelia cells or infusing with the gastrointestinal stem cells. Although the concept of cell-based therapy for various diseases of the gastrointestinal is widely accepted, the practical approach in humans remains difficult. Here we discussed the recent published data on clinical and experimental bone marrow stem cell transplantation and the possible role of stem cells in gastrointestinal tissue repair.
Intraurethral muscle-derived cell injections increase leak point pressure in a rat model of intrinsic sphincter deficiency. [2007]To determine whether allogenic muscle-derived cells (MDCs) could restore sphincter function in rats with intrinsic sphincter deficiency (ISD). ISD denotes a malfunction of the urethral sphincter.
A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence. [2021]The purpose of the study was to assess safety and efficacy of autologous muscle derived cells for urinary sphincter repair (AMDC-USR) in female subjects with predominant stress urinary incontinence.
[Cell therapy for urethral sphincter incompetence by muscle precursor cell autograft]. [2006]This article reviews cell therapy for muscle diseases and describes the development of a treatment for urethral sphincter insufficiency by muscle precursor cell (MPC) autograft. These studies were conducted in several successive steps, comprising: 1) comparative study of the cellular mechanisms of regeneration of skeletal striated muscle and urethral striated sphincter and development of a method of extraction of MPC; 2) creation of an animal model of sphincter injury reproducing chronic denervation lesions and fibrosis responsible for sphincter insufficiency in human; 3) study of the biology of intrasphincteric transplantation of MPC extracted from peripheral muscle, taking into account the interactions between these cells and the peripheral nervous system.
Autologous Muscle-Derived Cell Therapy for Swallowing Impairment in Patients Following Treatment for Head and Neck Cancer. [2023]To evaluate the safety and potential efficacy of autologous muscle-derived cells (AMDCs) for the treatment of swallowing impairment following treatment for oropharynx cancer.
Bioengineering functional human sphincteric and non-sphincteric gastrointestinal smooth muscle constructs. [2018]Digestion and motility of luminal content through the gastrointestinal (GI) tract are achieved by cooperation between distinct cell types. Much of the 3 dimensional (3D) in vitro modeling used to study the GI physiology and disease focus solely on epithelial cells and not smooth muscle cells (SMCs). SMCs of the gut function either to propel and mix luminal contents (phasic; non-sphincteric) or to act as barriers to prevent the movement of luminal materials (tonic; sphincteric). Motility disorders including pyloric stenosis and chronic intestinal pseudoobstruction (CIPO) affect sphincteric and non-sphincteric SMCs, respectively. Bioengineering offers a useful tool to develop functional GI tissue mimics that possess similar characteristics to native tissue. The objective of this study was to bioengineer 3D human pyloric sphincter and small intestinal (SI) constructs in vitro that recapitulate the contractile phenotypes of sphincteric and non-sphincteric human GI SMCs. Bioengineered 3D human pylorus and circular SI SMC constructs were developed and displayed a contractile phenotype. Constructs composed of human pylorus SMCs displayed tonic SMC characteristics, including generation of basal tone, at higher levels than SI SMC constructs which is similar to what is seen in native tissue. Both constructs contracted in response to potassium chloride (KCl) and acetylcholine (ACh) and relaxed in response to vasoactive intestinal peptide (VIP). These studies provide the first bioengineered human pylorus constructs that maintain a sphincteric phenotype. These bioengineered constructs provide appropriate models to study motility disorders of the gut or replacement tissues for various GI organs.
Functional restoration of ex vivo model of pylorus: Co-injection of neural progenitor cells and interstitial cells of Cajal. [2021]Transplantation of neural stem cells is a promising approach in treatment of intestinal dysfunctionality. The interstitial cells of Cajal (ICCs) are also critical in conditions such as pyloric dysfunctionality and gastroparesis. The objective of this study was to replenish neurons and ICCs in a dysfunctional pylorus as cell-based therapy to restore functionality. ICCs and enteric neural progenitor cells (NPCs) were isolated from rat duodenum and transduced with fluorescent proteins. Rat pylorus was harvested, and an ex-vivo neuromuscular dysfunctional model was developed by selective ablation of neurons and ICCs via chemical treatments. Cellular repopulation and restoration of motility were assessed by immunohistochemistry, qPCR, and functional analysis after delivery of fluorescently tagged cells. Chemical treatment of pylorus resulted in significant depletion of ICCs (67%, P = .0024; n = 3) and neural cells (83%, P = .0012; n = 3). Delivered ICCs and NPCs survived and integrated with host muscle layers. Co-injection of ICCs with NPCs exhibited 34.4% (P = .0004; n = 3) and 61.0% (P = .0003; n = 3) upregulation of ANO1 and βIII tubulin, respectively. This regeneration resulted in the restoration of agonist-induced excitatory contraction (82%) and neuron evoked relaxation (83%). The functional studies with specific neuronal nitric oxide (NO) synthase blocker confirmed that restoration of relaxation was NO mediated and neuronally derived. The simultaneous delivery of ICCs observed 35.7% higher neuronal differentiation and functional restoration compared with injection of NPCs alone. Injected NPCs and ICCs integrated into the dysfunctional ex vivo pylorus tissues and restored neuromuscular functionality. The co-transplantation of NPCs and ICCs can be used to treat neurodegenerative disorders of the pylorus.
Novel murine xenograft model for the evaluation of stem cell therapy for profound dysphagia. [2018]Dysphagia is common and costly. Treatments are limited and innovative therapies are required. The tongue is essential for safe, effective swallowing and is a natural target for regenerative therapy. Muscle-derived stem cells (MDSCs) hold potential to restore dynamic function, and their application in the damaged tongue is appealing. We examined the safety and efficacy of human MDSC implantation into a novel mouse tongue model.
Upper Gastrointestinal Motility, Disease and Potential of Stem Cell Therapy. [2023]Many gastrointestinal motility disorders arise due to defects in the enteric nervous system. Achalasia and gastroparesis are two extremely debilitating digestive diseases of the upper gastrointestinal tract caused in part by damage or loss of the nitrergic neurons in the esophagus and stomach. Most current pharmacological and surgical interventions provide no long-term relief from symptoms, and none address the cause. Stem cell therapy, to replace the missing neurons and restore normal gut motility, is an attractive alternative therapy. However, there are a number of hurdles that must be overcome to bring this exciting research from the bench to the bedside.
Safety and feasibility of fat injection therapy with adipose-derived stem cells in a rabbit hypoglossal nerve paralysis model: A pilot study. [2021]The aim of this study is to establish a unilateral tongue atrophy model by cutting the hypoglossal nerve and to evaluate the safety and feasibility of a fat injection of adipose-derived stem cells (ADSCs) to restore swallowing function.