A Phase 2 interventional study of Amimestrocel injection in Oral Mucositis, Stomatitis and Gastrointestinal Mucositis, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2, Interventional, and Prevention
This study aims to see if a single intravenous infusion of a cell therapy called Amimestrocel injection can help prevent severe mouth sores (oral mucositis) in patients receiving a stem cell transplant.
Patients getting a stem cell transplant often receive strong chemotherapy (with radiation and/or a drug called melphalan) that can cause painful mouth and gut sores, making eating difficult and increasing infection risk. Amimestrocel injection is made from human umbilical cord cells that may help reduce inflammation and promote healing.
About 22 adult patients scheduled for this type of transplant at one hospital in China will receive the infusion 1-2 days before their stem cell transplant. Researchers will closely check for mouth sores, pain, and side effects for the first 28 days, and continue safety monitoring for 100 days.
The main goal is to see if the treatment lowers the rate of severe (Grade 3-4) mouth sores. The study will also track pain levels, need for pain medication, diarrhea, time for blood counts to recover, and overall safety.
Background and Rationale:
Myeloablative conditioning regimens containing total body irradiation (TBI) and/or high-dose melphalan are standard prior to allogeneic hematopoietic stem cell transplantation (HSCT) but frequently cause severe gastrointestinal mucositis. This condition leads to significant morbidity, including pain, dysphagia, diarrhea, nutritional impairment, infection risk, prolonged hospitalization, and increased costs. Effective preventive strategies are limited. Mesenchymal stem cells (MSCs) have demonstrated immunomodulatory and tissue-repair properties via paracrine secretion of anti-inflammatory and growth factors, showing potential in mitigating mucosal injury in preclinical and early clinical contexts.
Study Design:
This is a single-arm, single-center, open-label, exploratory interventional study. It will enroll approximately 22 subjects to preliminarily evaluate the efficacy and safety of prophylactic Amimestrocel infusion.
Intervention:
Eligible patients will receive a single, fixed-dose intravenous infusion of Amimestrocel injection (6.0×10⁷ cells in 150 mL) within 24 to 48 hours after the last dose of cyclophosphamide (part of the standard conditioning regimen) and before the infusion of hematopoietic stem cells (Day 0).
Study Population:
Adults aged 18-65 years planned for myeloablative allogeneic HSCT with a TBI and/or melphalan-containing conditioning regimen, with adequate organ function and ECOG status 0-1. Key exclusions include active uncontrolled infection, allergy to MSCs, prior cell therapy, and pregnancy.
Endpoints and Assessments:
Primary Endpoint: Incidence of Grade 3-4 oral mucositis (assessed daily by WHO/NCI-CTCAE criteria) within 28 days post-transplant (Day 0 to +28).
Secondary Endpoints: Duration/severity of oral and gastrointestinal mucositis; oral pain (Numerical Rating Scale); opioid use; time to neutrophil engraftment (ANC ≥0.5×10⁹/L); incidence of adverse events and serious adverse events (monitored until Day +100).
Sample Size Justification:
The sample size of 22 is derived from an assumption of reducing the historical incidence of severe oral mucositis (71% based on literature) to 41% (30% absolute reduction), with 80% power and a two-sided alpha of 0.05, accounting for a 10% dropout rate.
Study Procedures Overview:
The process includes a screening period (Day -14 to -7), the investigational product infusion, an intensive observation phase (Day 0 to +28) with daily mucositis and pain assessments, and a safety follow-up phase until Day +100 for AE/SAE monitoring, GVHD, and survival status.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 22 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 261 studies on the registry; 150 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled participants will receive a single, fixed-dose intravenous infusion of Amimestrocel injection (6.0×10⁷ cells in 12mL). The infusion is administered within 24 to 48 hours after the last dose of cyclophosphamide (part of the standard conditioning regimen) and before the infusion of hematopoietic stem cells (Day 0). All participants will also undergo standard myeloablative conditioning (containing TBI and/or melphalan), allogeneic hematopoietic stem cell transplantation, and institutional standard supportive care.
Biological: Amimestrocel injection
Amimestrocel injection is an allogeneic (donor-derived), umbilical cord mesenchymal stem cell (UC-MSC) suspension for intravenous infusion. It is supplied as a cryopreserved cell suspension in a single-dose bag containing 6.0×10⁷ viable cells in 12 mL. For this study, a single bag is thawed and administered as a one-time intravenous infusion.
Also known as: Ruibo Sheng
Incidence of Grade 3-4 Oral Mucositis within 28 Days Post-Transplant
The proportion of subjects who develop severe (Grade 3 or 4) oral mucositis from the transplant day (Day 0) up to Day 28 post-transplant. The severity of oral mucositis is assessed daily and the highest grade recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Time frame: From stem cell infusion (Day 0) up to Day 28 post-transplant
Maximum Severity Grade of Oral Mucositis
The highest severity grade of oral mucositis experienced by the subject from Day 0 to Day 28 post-transplant. Grading is based on the NCI CTCAE v5.0 criteria (Grades 1-5). Results are described as the number and percentage of patients in each grade.
Time frame: From Day 0 up to Day 28 post-transplant.
Duration of Oral Mucositis
The number of days from the first date of onset of ≥ Grade 2 oral mucositis to the first date it resolves to ≤ Grade 1. For subjects who do not develop ≥ Grade 2 mucositis or whose condition does not resolve to ≤ Grade 1 within 28 days, the duration will be censored. Results are described as median and interquartile range.
Time frame: From Day 0 up to Day 28 post-transplant.
Maximum Severity Grade of Diarrhea
The highest severity grade of non-infectious diarrhea experienced by the subject from Day 0 to Day 28 post-transplant. Grading is based on the NCI CTCAE v5.0 criteria (Grades 1-5). Results are described as the number and percentage of patients in each grade.
Time frame: From Day 0 up to Day 28 post-transplant.
Total Duration of ≥ Grade 2 Diarrhea
The sum total of days the subject experiences non-infectious diarrhea of severity ≥ Grade 2 from Day 0 to Day 28 post-transplant. Results are described as median and interquartile range.
Time frame: From Day 0 up to Day 28 post-transplant.
Peak Oral Pain Score
The highest score recorded in the subject's daily self-assessed oral pain Numerical Rating Scale (NRS, 0-10) from Day 0 to Day 28 post-transplant. Results are described as median and interquartile range.
Time frame: The highest score recorded in the subject's daily self-assessed oral pain Numerical Rating Scale (NRS, 0-10) from Day 0 to Day 28 post-transplant. Results are described as median and interquartile range.
Total Opioid Use from Day 0 to Day 28 Post-Transplant
The total consumption of opioids for controlling oral mucositis-related pain from Day 0 to Day 28 post-transplant, converted to oral morphine milligram equivalents (MME). Results are described as median and interquartile range.
Time frame: From Day 0 up to Day 28 post-transplant.
Time to Neutrophil Engraftment
The number of days from Day 0 to the first of three consecutive days with an absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L. Estimated using the Kaplan-Meier method.
Time frame: From Day 0 up to Day 60 post-transplant.
Incidence of Any Adverse Event (AE) within 100 Days Post-Transplant
The proportion of subjects who experience any grade of adverse event (AE) from after the investigational product infusion up to Day 100 post-transplant. The severity and relationship to the investigational product are assessed according to NCI CTCAE v5.0 criteria and protocol specifications.
Time frame: From after investigational product infusion up to Day 100 post-transplant.
Incidence of Serious Adverse Events (SAEs) within 100 Days Post-Transplant
The proportion of subjects who experience any serious adverse event (SAE) from after the investigational product infusion up to Day 100 post-transplant. SAE definition follows ICH-GCP guidelines.
Time frame: From after investigational product infusion up to Day 100 post-transplant.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Feb 2026 (actual). Primary completion is estimated for May 2027, 15 months after the start.
Of 39 phase 2 interventional studies under Stomatitis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 15 months is below that.
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The First Affiliated Hospital of Soochow University →