Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
Recruiting
Phase 2
Interventional Study
Oral Mucositis
Stomatitis
Gastrointestinal Mucositis
Hematopoietic Stem Cell Transplantation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 22 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Other
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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 in…
Trial Locations
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Eligibility Criteria
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. A…
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