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New treatment option for Oral Mucositis
Official title Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
ClinicalTrials.gov ID: NCT07400328
What this study is testing
What is Amimestrocel injection?
Amimestrocel injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for oral mucositis.
Also referred to as Ruibo Sheng.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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.
- Previous receipt of any cell therapy product.
- Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures.
See the full eligibility 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.
- 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.
- Previous receipt of any cell therapy product.
- Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures.
- Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhu, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhu, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.