Actively Recruiting
Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-14
22
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years.
- Planned to undergo myeloablative allogeneic hematopoietic stem cell transplantation.
- Conditioning regimen includes total body irradiation and/or melphalan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function: Left ventricular ejection fraction 50%; serum total bilirubin 1.5 times upper limit of normal; serum creatinine 1.5 times upper limit of normal or creatinine clearance 60 mL/min.
- Voluntarily signs the informed consent form.
You will not qualify if you...
- Allergy to mesenchymal stem cells or any component of Amimestrocel injection.
- Active, uncontrolled bacterial, fungal, or viral infection.
- History of other malignancies within the past 5 years, except cured carcinoma in situ or basal cell skin cancer.
- Pregnant or lactating women, or planning pregnancy during the study.
- Previous receipt of any cell therapy product.
- Severe psychiatric disorder or cognitive impairment limiting consent or compliance.
- Any condition judged by the investigator as unsuitable for participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China, 215006
Actively Recruiting
Research Team
D
depei Wu Study Coordinator
CONTACT
X
xiaojin Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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