The incidence of severe oral mucositis in patients undergoing different conditioning regimens in haematopoietic stem cell transplantation.
Midori Nakagaki, Glen A Kennedy, Nicole C Gavin...
https://pubmed.ncbi.nlm.nih.gov/36008731Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID07400328
A Single-Arm, Single-Center Study of Amimestrocel Injection to Prevent Gastrointestinal Mucositis Caused by Conditioning with Total Body Irradiation and/or Melphalan
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-14
22
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates whether a single intravenous infusion of Amimestrocel injection, a cell therapy made from human umbilical cord mesenchymal stem cells, can help reduce severe mouth sores called oral mucositis in adults undergoing myeloablative allogeneic hematopoietic stem cell transplantation (HSCT). This painful side effect commonly occurs due to strong chemotherapy regimens containing total body irradiation (TBI) and/or melphalan. The study is a Phase 2, single-center, open-label exploratory trial involving about 22 adult patients aged 18 to 65 years. Participants will receive a single fixed dose of Amimestrocel injection (6.0 × 10^7 cells in 12 mL) intravenously within 24 to 48 hours after the last dose of cyclophosphamide, which is part of the standard conditioning regimen, and before the stem cell infusion (Day 0). All patients will also undergo standard myeloablative conditioning containing TBI and/or melphalan, followed by allogeneic stem cell transplantation and standard supportive care. During the study, patients will be closely monitored daily for the presence and severity of oral mucositis and pain for 28 days after transplant. Researchers will assess pain levels, opioid use, diarrhea, and time until blood counts recover. Safety will be followed for 100 days post-transplant, including adverse events and serious adverse events. The main outcome is the incidence of severe (Grade 3-4) oral mucositis within 28 days after transplant.
CONDITIONS
Brief Title
Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
Who Can Participate
Age: 18Years - 65Years
All Genders
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 × upper limit of normal, serum creatinine ≤ 1.5 × 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 past 5 years, except cured carcinoma in situ or basal cell skin cancer
- Pregnant or lactating women, or planning pregnancy during study
- Previous receipt of any cell therapy product
- Severe psychiatric disorder or cognitive impairment limiting consent or compliance
- Any condition making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 1 to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day
Participants receive a single intravenous infusion of Amimestrocel injection within 24 to 48 hours after the last dose of cyclophosphamide and prior to stem cell infusion.
1 visit (in-person)
Monitoring
Duration - 28 days
Participants are observed daily for oral mucositis and oral pain from the day of stem cell infusion up to 28 days post-transplant.
Daily visits or assessments for 28 days
Follow-up
Duration - Up to 100 days
Participants are monitored for adverse events, serious adverse events, graft-versus-host disease, and survival status up to 100 days after transplant.
Periodic visits or assessments up to Day 100
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China, 215006
Actively Recruiting
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Research Team
D
depei Wu Study Coordinator
X
xiaojin Wu
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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Partow Kebriaei, Jack Hayes, Andrew Daly...
https://pubmed.ncbi.nlm.nih.gov/31505228Promotion of Epithelial Healing in Oral Mucositis by hESC-derived Mesenchymal Stem Cells via the PI3K/AKT Pathway.
Kejia Lv, Bicong Gao, Weijia Ye...
https://pubmed.ncbi.nlm.nih.gov/41147081Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study.
Katarina Le Blanc, Francesco Frassoni, Lynne Ball...
https://pubmed.ncbi.nlm.nih.gov/18468541The pathobiology of mucositis.
Stephen T Sonis
https://pubmed.ncbi.nlm.nih.gov/15057287