Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients

NCT07400328 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Phase 2

Started

2026-02-15

Last updated

2026-04-14

Condition(s) studied

Oral MucositisStomatitisGastrointestinal MucositisHematopoietic Stem Cell Transplantation

Investigational drug(s) / intervention(s)

Amimestrocel injection →

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Aged 18 to 65 years. 2. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplantation. 3. The conditioning regimen must contain total body irradiation (TBI) and/or melphalan. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function defined as:Left ventricular ejection fraction (LVEF) ≥ 50%.Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min. 6. Voluntarily signs the informed consent form. Exclusion Criteria: 1. History of allergy to mesenchymal stem cells or any component of the Amimestrocel injection preparation. 2. Presence of active, uncontrolled bacterial, fungal, or viral infection. 3. History of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell skin cancer. 4. Pregnant or lactating women, or those planning pregnancy during the study period. 5. Previous receipt of any cell therapy product. 6. Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures. 7. Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.

Primary outcome measure(s)

Incidence of Grade 3-4 Oral Mucositis within 28 Days Post-Transplant — From stem cell infusion (Day 0) up to Day 28 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.

Trial sites (1)

Facility	City	Region	Status
First Affiliated Hospital of Soochow University	Suzhu	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07400328 on ClinicalTrials.gov ↗ ← All trials in China