Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Amimestrocel injection
Biological/VaccineAmimestrocel injection is an allogeneic (donor-derived), umbilical cord mesenchymal stem cell (UC-MSC) suspension for intravenous infusion. It is supplied as a cryopreserved cell suspension in a single-dose bag containing 6.0×10⁷ viable cells in 12 mL. For this study, a single bag is thawed and administered as a one-time intravenous infusion.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Amimestrocel InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Grade 3-4 Oral Mucositis within 28 Days Post-Transplant
The proportion of subjects who develop severe (Grade 3 or 4) oral mucositis from the transplant day (Day 0) up to Day 28 post-transplant. The severity of oral mucositis is assessed daily and the highest grade recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Time frame
From stem cell infusion (Day 0) up to Day 28 post-transplantSecondary outcomes
1
Maximum Severity Grade of Oral Mucositis
The highest severity grade of oral mucositis experienced by the subject from Day 0 to Day 28 post-transplant. Grading is based on the NCI CTCAE v5.0 criteria (Grades 1-5). Results are described as the number and percentage of patients in each grade.
Time frame
From Day 0 up to Day 28 post-transplant.2
Duration of Oral Mucositis
The number of days from the first date of onset of ≥ Grade 2 oral mucositis to the first date it resolves to ≤ Grade 1. For subjects who do not develop ≥ Grade 2 mucositis or whose condition does not resolve to ≤ Grade 1 within 28 days, the duration will be censored. Results are described as median and interquartile range.
Time frame
From Day 0 up to Day 28 post-transplant.3
Maximum Severity Grade of Diarrhea
The highest severity grade of non-infectious diarrhea experienced by the subject from Day 0 to Day 28 post-transplant. Grading is based on the NCI CTCAE v5.0 criteria (Grades 1-5). Results are described as the number and percentage of patients in each grade.
Time frame
From Day 0 up to Day 28 post-transplant.4
Total Duration of ≥ Grade 2 Diarrhea
The sum total of days the subject experiences non-infectious diarrhea of severity ≥ Grade 2 from Day 0 to Day 28 post-transplant. Results are described as median and interquartile range.
Time frame
From Day 0 up to Day 28 post-transplant.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
First Affiliated Hospital of Soochow UniversityRecruiting215006, Suzhu, Jiangsu
China
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Source ClinicalTrials.gov