Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients (NCT07400328) | Clinical Trial Compass
RecruitingPhase 2
Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
China22 participantsStarted 2026-02-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of Grade 3-4 Oral Mucositis within 28 Days Post-Transplant
Timeframe: From stem cell infusion (Day 0) up to Day 28 post-transplant
Trial details
NCT IDNCT07400328
SponsorThe First Affiliated Hospital of Soochow University