Amimestrocel infusion to prevent severe mouth sores after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label Phase 2 study enrolling about 22 adults at one center to test a single fixed dose of Amimestrocel (6.0×10^7 cells IV) given 24–48 hours after the last cyclophosphamide dose and before stem cell infusion. Patients will be followed closely for oral mucositis severity and pain over the first 28 days, with additional safety monitoring up to 100 days. The trial focuses on those receiving total body irradiation and/or high‑dose melphalan as part of myeloablative conditioning. Outcomes include the rate of severe (Grade 3–4) oral mucositis, analgesic use, and treatment-related adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital of Soochow University
  Suzhu, Jiangsu, China Recruiting

Study contacts

• Principal investigator: xiaojin Wu, Principal Investigator — The First Affiliated Hospital of Soochow University
• Study coordinator: depei Wu Study Coordinator
• Email: sdfyec@163.com
• Phone: +86-512-67972861

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.