Oropharyngeal DysphagiaPhase 1/2REVIVENCT05421689
Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia
A Phase 1/2 study testing Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) in people with Oropharyngeal Dysphagia, run by University of California, Davis at 2 sites in United States.
Trial summary
The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 May 2022to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, at least 18 years old, with primary symptoms of TD following surgery and/or chemo- and/or radiotherapy for treatment of squamous cell carcinoma for oropharyngeal cancer. Treatment must be completed at least 24 months prior to enrollment, with TD and disease-free status confirmed by medical history, clinical symptoms, a focused head and neck examination, swallowing fluoroscopy, and high-resolution pharyngeal manometry.
- TD severity should be moderate as defined by a Functional Oral Intake Scale (FOIS, provided in Appendix C). Individuals must have a FOIS of 3 or better and EAT-10 score of greater than 5.
- Patient has failed to achieve resolution of symptoms following contemporary therapies.
Who cannot join
- 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.
- Previously treated with an investigational device, drug, or procedure for TD within 6 months prior to signing consent.
- TD of neurogenic etiology or uncorrected congenital abnormality leading to TD.
- Neuromuscular disorder (e.g., Parkinson's disease, muscular dystrophy, multiple sclerosis) that could lead to TD.
- Severe fibrosis at injection site.
- Uncontrolled diabetes.
Show all 21Show fewer
- Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy.
- Medical condition or disorder that may limit life expectancy or that may cause CIP deviations (e.g., unable to perform self-evaluations or accurately report medical history, symptoms, or data).
- History of bleeding diathesis or uncorrectable coagulopathy.
- Known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, or ampicillin that medically warrants exclusion as determined by the physician.
- Any non-skin cancer that has necessitated treatment within the past 24 months.
- Patient's Current Status-based Criteria:
- Evidence or known high risk of recurrent or persistent cancer as determined by the physician during screening.
- Tests positive for Hepatitis B (required tests: Hepatitis B Surface Antigen [HBsAg] and Anti-Hepatitis B Core Antibody [Anti-HBc]), Hepatitis C (required test: Hepatitis C Antibody [Anti-HCV]), HIV (required tests: HIV Type 1 and 2 Antibodies [Anti-HIV-1, 2]), and/or Syphilis.
- Tests performed by certified/authorized testing laboratory using licensed/approved tests and performed on blood samples collected within 30 days prior to muscle tissue procurement.
- Cannot, or is not willing to maintain the current treatment regimen for existing contemporary therapy (e.g., swallowing therapy).
- Requires prophylactic antibiotics for chronic infection or has required 2 or more courses of antibiotics for infections in the 2 months prior to signing consent.
- Any condition, including current infection or immunodeficiency, which could lead to significant postoperative complications.
- Refuses or cannot provide written informed consent.
- Not available for, or willing to comply with the baseline and follow-up evaluations as required by the CIP.
- Pregnant, lactating, or plans to become pregnant during the course of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC Davis Medical Center, Department of Otolaryngology
Sacramento, California, 95817
UC San Francisco Medical Center, Voice and Swallow Center
San Francisco, California, 94115
About this study
Official title: A Multi-Center, Double-Blind, Randomized Placebo-Controlled Investigation of Autologous Muscle Derived Cells (AMDC) for the Treatment of Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer
The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments 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.
Read the detailed description
The purpose of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety and efficacy of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for the treatment of tongue dysphagia (TD) in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Surgery, chemo- and radiotherapy induce significant TD and result in long-term swallowing dysfunction. The incidence of TD after treatment for cancer of the pharynx exceeds 80%. Therefore, augmenting tongue muscle function may be beneficial to patients. Autologous muscle cell therapy, which involves isolation of cells from skeletal muscle biopsies, ex vivo expansion, and subsequent injection into the tongue, may serve as a durable therapy. In animal studies, muscle derived cells have successfully integrated within tissue to improve tongue strength and function. Intramuscular injection of AMDC-GIR has been shown to produce localized tissue changes at the injection site without a systemic effect. Initial results of a Phase 1 open label trial suggest that 150 x 10⁶ AMDC-GIR for the treatment of TD is safe and may be efficacious. A Phase I/II placebo controlled, randomized clinical trial is warranted.
Patients will receive two treatments of intramuscular injection of 1 AMDC-GIR dose of 150 x 10⁶ cells or identical placebo. For entrance into the study, patients must meet the study inclusion criterion and must not meet any of the exclusion criteria. Patients will have quantitative and qualitative measures of swallowing impairment assessed before treatment and at prescheduled intervals after treatment.
The study will treat 66 patients at 2 clinical sites: UC Davis Center for Voice and Swallowing and UCSF Voice and Swallowing Center. Patients will be randomized 1:1 to receive either 2 AMDC-GIR doses of 150 x 10⁶ cells or 2 doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Enrollment is expected to be completed within 2 years of initiating the study. Patients will be followed for 24 months post-treatment.
Male and female patients at least 18 years of age who have undergone surgery and/or chemo- and/or radiotherapy for primary treatment of oropharyngeal squamous cell cancer and who present with symptoms and findings of TD will be eligible for participation. Eligible patients will have muscle tissue harvested using an established needle biopsy technique during an outpatient procedure.
The harvested muscle will be placed in a hypothermic medium and transported to the manufacturer for cell processing. The muscle derived cells (MDC) will be isolated and expanded in culture over several weeks to a final AMDC-GIR dose of 150 x 10⁶ cells. Each patient will receive 2 doses of cells or placebo spaced 4-6 weeks apart.
After reaching the desired concentration, the isolated and expanded AMDC-GIR or identical placebo will be frozen and shipped back to the investigating physician. The investigative team will thaw the AMDC-GIR and dilute the sample with an equal volume of physiological saline. Under direct vision, the resulting suspension will be injected into the patient's tongue in a brief outpatient procedure for the patients randomized to the treatment arm. Patients randomized to receive placebo will undergo an identical procedure utilizing a thawed solution of frozen media without cells. Both patient and clinician will be blind to the treatment and placebo status.
Patients will be assessed for improvement in TD at 6 months, 12 months and 18 months and 24 months following treatment. Adverse events will be assessed at those visits, as well as during virtual visits at 1-2 days, 1 week, 4 weeks, 3 months, 15 months, 21 months and 24 months. Adverse events will also be assessed at 6 months post-injection in patients who were in the placebo group and elected to receive AMDC_GIR injections after the unblinding. Patient reported outcome measures will be assessed at 4 weeks, 3 months, 6 months, 12 months, 18 months and 24 months.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR), Placebo
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)Biological
Also called Autologous muscle derived stem cells
The study will treat 66 patients at 2 clinical sites: UC Davis Center for Voice and Swallowing and UCSF Voice and Swallowing Center. Patients will be randomized 1:1 to receive either 2 AMDC-GIR doses of 150 x 10⁶ cells or 2 doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Enrollment is expected to be completed within 2 years of initiating the study. Patients will be followed for 24 months post-treatment.
PlaceboOther
Also called identical placebo composed of the same cryopreservation medium used for AMDC-GIR
two doses of placebo will be administered and spaced 4-6 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 150 x 10⁶ AMDC-GIR dosage | Experimental | 33 subjects will be receiving two doses of 150 x 10⁶ AMDC-GIR spaced 4-6 weeks apart. Receives: Biological: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) |
| Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR | Sham comparator | 33 subjects will be receiving two doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Doses will be spaced 4-6 weeks apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study product-related, biopsy procedure-related, and injection procedure-related adverse events.
Safety will be determined by the frequency and severity of adverse events related to study procedures and study product.
Measured: 24 months
Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI)
Efficacy of AMDC-GIR in the improvement of objective Anterior Tongue Pressure Measurement (IOPI)
Measured: 24 months
Secondary outcomes (5)
Incidence of patient aspiration pneumonia
Effects of AMDC-GIR on incidence of patient reported aspiration pneumonia (yes/no scoring criteria)
Measured: 24 months
Incidence of patient survival
Effects of AMDC-GIR on incidence of patient reported survival (yes/no scoring criteria)
Measured: 24 months
Penetration Aspiration scale rating following swallowing fluoroscopy
The 8-point Penetration-Aspiration Scale (scores of 1-8, 1=better, 8=worse, see table below) is the standard method used measure the severity of airway invasion during swallowing.
- Material does not enter the airway
- Material enters the airway, remains above the vocal folds, and is ejected from the airway
- Material enters the airway, remains above the vocal folds, and is not ejected from the airway
- Material enters the airway, contacts the vocal folds, and is ejected from the airway
- Material enters the airway, contacts the vocal folds, and is not ejected from the airway
- Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway
- Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort
- Material enters the airway, passes below the vocal folds, and no effort is made to eject
Measured: 24 months
Peak Pharyngeal pressure measurement from high-resolution manometry
Efficacy of AMDC-GIR in the improvement of objective manometric swallowing parameters
Measured: 24 months
Patient-reported dysphagia symptoms based on Eating Assessment Tool EAT10 score
Survey consisting of 10 questions (see table below), each score on a scale of 0-4, with 0= no problem, 4= severe problem.
922 Belafsky et al. Eating Assessment Tool TABLE 3. EATING ASSESSMENT TOOL (EAT-10) Circle the appropriate response. To what extent are the following scenarios problematic for you?
- My swallowing problem has caused me to lose weight.
- My swallowing problem interferes with my ability to go out for meals.
- Swallowing liquids takes extra effort.
- Swallowing solids takes extra effort.
- Swallowing pills takes extra effort.
- Swallowing is painful.
- The pleasure of eating is affected by my swallowing.
- When I swallow food sticks in my throat.
- I cough when I eat.
- Swallowing is stressful
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start26 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled, multicenter clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Institute for Regenerative Medicine (CIRM), Cook MyoSite
- Responsible party
- Sponsor
- Investigators
- Peter Belafsky, MD, Principal investigator, University of California Davis, Department of OtolaryngologyMaggie Kuhn, MD, Principal investigator, University of California Davis, Department of OtolaryngologyJohnathon D Anderson, PhD, Study director, University of California Davis, Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421689
- Sponsor's protocol ID
- 1800521
- Other IDs
- 1800521
- Acronym
- REVIVE
- Status last verified
- Dec 2025
- First submitted
- 6 Jun 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized Placebo-Controlled Investigation of Autologous Muscle Derived Cells (AMDC) for the Treatment of Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05421689
- Acronym / sponsor ID
- REVIVE / 1800521
- Conditions
- Oropharyngeal Dysphagia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Institute for Regenerative Medicine (CIRM), Cook MyoSite
- Study start
- 26 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments 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.
Detailed description
The purpose of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety and efficacy of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for the treatment of tongue dysphagia (TD) in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Surgery, chemo- and radiotherapy induce significant TD and result in long-term swallowing dysfunction. The incidence of TD after treatment for cancer of the pharynx exceeds 80%. Therefore, augmenting tongue muscle function may be beneficial to patients. Autologous muscle cell therapy, which involves isolation of cells from skeletal muscle biopsies, ex vivo expansion, and subsequent injection into the tongue, may serve as a durable therapy. In animal studies, muscle derived cells have successfully integrated within tissue to improve tongue strength and function. Intramuscular injection of AMDC-GIR has been shown to produce localized tissue changes at the injection site without a systemic effect. Initial results of a Phase 1 open label trial suggest that 150 x 10⁶ AMDC-GIR for the treatment of TD is safe and may be efficacious. A Phase I/II placebo controlled, randomized clinical trial is warranted.
Patients will receive two treatments of intramuscular injection of 1 AMDC-GIR dose of 150 x 10⁶ cells or identical placebo. For entrance into the study, patients must meet the study inclusion criterion and must not meet any of the exclusion criteria. Patients will have quantitative and qualitative measures of swallowing impairment assessed before treatment and at prescheduled intervals after treatment.
The study will treat 66 patients at 2 clinical sites: UC Davis Center for Voice and Swallowing and UCSF Voice and Swallowing Center. Patients will be randomized 1:1 to receive either 2 AMDC-GIR doses of 150 x 10⁶ cells or 2 doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Enrollment is expected to be completed within 2 years of initiating the study. Patients will be followed for 24 months post-treatment.
Male and female patients at least 18 years of age who have undergone surgery and/or chemo- and/or radiotherapy for primary treatment of oropharyngeal squamous cell cancer and who present with symptoms and findings of TD will be eligible for participation. Eligible patients will have muscle tissue harvested using an established needle biopsy technique during an outpatient procedure.
The harvested muscle will be placed in a hypothermic medium and transported to the manufacturer for cell processing. The muscle derived cells (MDC) will be isolated and expanded in culture over several weeks to a final AMDC-GIR dose of 150 x 10⁶ cells. Each patient will receive 2 doses of cells or placebo spaced 4-6 weeks apart.
After reaching the desired concentration, the isolated and expanded AMDC-GIR or identical placebo will be frozen and shipped back to the investigating physician. The investigative team will thaw the AMDC-GIR and dilute the sample with an equal volume of physiological saline. Under direct vision, the resulting suspension will be injected into the patient's tongue in a brief outpatient procedure for the patients randomized to the treatment arm. Patients randomized to receive placebo will undergo an identical procedure utilizing a thawed solution of frozen media without cells. Both patient and clinician will be blind to the treatment and placebo status.
Patients will be assessed for improvement in TD at 6 months, 12 months and 18 months and 24 months following treatment. Adverse events will be assessed at those visits, as well as during virtual visits at 1-2 days, 1 week, 4 weeks, 3 months, 15 months, 21 months and 24 months. Adverse events will also be assessed at 6 months post-injection in patients who were in the placebo group and elected to receive AMDC_GIR injections after the unblinding. Patient reported outcome measures will be assessed at 4 weeks, 3 months, 6 months, 12 months, 18 months and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled, multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: 150 x 10⁶ AMDC-GIR dosage | Experimental | Biological: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)33 subjects will be receiving two doses of 150 x 10⁶ AMDC-GIR spaced 4-6 weeks apart. |
| Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR | Sham comparator | Other: Placebo33 subjects will be receiving two doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Doses will be spaced 4-6 weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female, at least 18 years old, with primary symptoms of TD following surgery and/or chemo- and/or radiotherapy for treatment of squamous cell carcinoma for oropharyngeal cancer. Treatment must be completed at least 24 months prior to enrollment, with TD and disease-free status confirmed by medical history, clinical symptoms, a focused head and neck examination, swallowing fluoroscopy, and high-resolution pharyngeal manometry.
- TD severity should be moderate as defined by a Functional Oral Intake Scale (FOIS, provided in Appendix C). Individuals must have a FOIS of 3 or better and EAT-10 score of greater than 5.
- Patient has failed to achieve resolution of symptoms following contemporary therapies.
Key exclusion criteria (21 listed)
- 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.
- Previously treated with an investigational device, drug, or procedure for TD within 6 months prior to signing consent.
- TD of neurogenic etiology or uncorrected congenital abnormality leading to TD.
- Neuromuscular disorder (e.g., Parkinson's disease, muscular dystrophy, multiple sclerosis) that could lead to TD.
- Severe fibrosis at injection site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)Also: Autologous muscle derived stem cellsThe study will treat 66 patients at 2 clinical sites: UC Davis Center for Voice and Swallowing and UCSF Voice and Swallowing Center. Patients will be randomized 1:1 to receive either 2 AMDC-GIR doses of 150 x 10⁶ cells or 2 doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Enrollment is expected to be completed within 2 years of initiating the study. Patients will be followed for 24 months post-treatment. | Biological | Experimental: 150 x 10⁶ AMDC-GIR dosage |
| PlaceboAlso: identical placebo composed of the same cryopreservation medium used for AMDC-GIRtwo doses of placebo will be administered and spaced 4-6 weeks apart. | Other | Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR |
Primary outcome
Study product-related, biopsy procedure-related, and injection procedure-related adverse events.
Time frame: 24 months
Safety will be determined by the frequency and severity of adverse events related to study procedures and study product.
Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI)
Time frame: 24 months
Efficacy of AMDC-GIR in the improvement of objective Anterior Tongue Pressure Measurement (IOPI)
5 secondary outcomes
Incidence of patient aspiration pneumonia
Time frame: 24 months
Incidence of patient survival
Time frame: 24 months
Penetration Aspiration scale rating following swallowing fluoroscopy
Time frame: 24 months
Peak Pharyngeal pressure measurement from high-resolution manometry
Time frame: 24 months
Patient-reported dysphagia symptoms based on Eating Assessment Tool EAT10 score
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Belafsky, MD principal investigator
University of California Davis, Department of Otolaryngology
Maggie Kuhn, MD principal investigator
University of California Davis, Department of Otolaryngology
Johnathon D Anderson, PhD study director
University of California Davis, Department of Otolaryngology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) in people with Oropharyngeal Dysphagia, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study product-related, biopsy procedure-related, and injection procedure-related adverse events. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.