Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients

Recruiting now · Phase 2

Conditions studied: Oral Mucositis, Stomatitis, Gastrointestinal Mucositis, Hematopoietic Stem Cell Transplantation

In brief

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.

Key facts

Study ID

NCT07400328

Run by

The First Affiliated Hospital of Soochow University

People needed

22

Starts

2026-02-15

Expected to finish

2028-01-31

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 to 65 years.
• Planned to undergo myeloablative allogeneic hematopoietic stem cell transplantation.
• The conditioning regimen must contain total body irradiation (TBI) and/or melphalan.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 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.
• Voluntarily signs the informed consent form.

You may not qualify if…

• History of allergy to mesenchymal stem cells or any component of the Amimestrocel injection preparation.
• Presence of active, uncontrolled bacterial, fungal, or viral infection.
• History of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell skin cancer.
• Pregnant or lactating women, or those planning pregnancy during the study period.
• Previous receipt of any cell therapy product.
• Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures.
• Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.

Where it is running

• First Affiliated Hospital of Soochow University — Suzhu, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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