Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients

NCT07400328 | Recruiting Phase 2

• 1 other identifier: SOOCHOW-WXJ-2025-1292
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Mucositis; Stomatitis; Gastrointestinal Mucositis; Hematopoietic Stem Cell Transplantation

Keywords

Amimestrocel; Mesenchymal Stem Cells; Umbilical Cord; Mucositis Prevention; Total Body Irradiation; Melphalan; Conditioning Regimen; Allogeneic Transplantation; Single-Arm Trial

Outcome Measures

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.

  From stem cell infusion (Day 0) up to Day 28 post-transplant

Secondary Outcomes (9)

• Maximum Severity Grade of Oral Mucositis

  From Day 0 up to Day 28 post-transplant.

• Duration of Oral Mucositis

  From Day 0 up to Day 28 post-transplant.

• Maximum Severity Grade of Diarrhea

  From Day 0 up to Day 28 post-transplant.

• Total Duration of ≥ Grade 2 Diarrhea

  From Day 0 up to Day 28 post-transplant.

• Peak Oral Pain Score

  The highest score recorded in the subject's daily self-assessed oral pain Numerical Rating Scale (NRS, 0-10) from Day 0 to Day 28 post-transplant. Results are described as median and interquartile range.

Study Arms (1)

Amimestrocel Injection

EXPERIMENTAL

All enrolled participants will receive a single, fixed-dose intravenous infusion of Amimestrocel injection (6.0×10⁷ cells in 12mL). The infusion is administered within 24 to 48 hours after the last dose of cyclophosphamide (part of the standard conditioning regimen) and before the infusion of hematopoietic stem cells (Day 0). All participants will also undergo standard myeloablative conditioning (containing TBI and/or melphalan), allogeneic hematopoietic stem cell transplantation, and institutional standard supportive care.

Biological: Amimestrocel injection

Interventions

Amimestrocel injection BIOLOGICAL

Amimestrocel 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.

Also known as: Ruibo Sheng

Amimestrocel Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min.
• Voluntarily signs the informed consent form.

You may not qualify 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.
• Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhu, Jiangsu, 215006, China

RECRUITING

Related Publications (5)

• Nakagaki M, Kennedy GA, Gavin NC, Clavarino A, Whitfield K. The incidence of severe oral mucositis in patients undergoing different conditioning regimens in haematopoietic stem cell transplantation. Support Care Cancer. 2022 Nov;30(11):9141-9149. doi: 10.1007/s00520-022-07328-4. Epub 2022 Aug 26.

  PMID: 36008731 BACKGROUND

• Kebriaei P, Hayes J, Daly A, Uberti J, Marks DI, Soiffer R, Waller EK, Burke E, Skerrett D, Shpall E, Martin PJ. A Phase 3 Randomized Study of Remestemcel-L versus Placebo Added to Second-Line Therapy in Patients with Steroid-Refractory Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2020 May;26(5):835-844. doi: 10.1016/j.bbmt.2019.08.029. Epub 2019 Sep 7.

  PMID: 31505228 BACKGROUND

• Lv K, Gao B, Ye W, Shen C, Chen T, Wang C, Yao H. Promotion of Epithelial Healing in Oral Mucositis by hESC-derived Mesenchymal Stem Cells via the PI3K/AKT Pathway. Curr Stem Cell Res Ther. 2025;20(7):810-823. doi: 10.2174/011574888X338333241010104024.

  PMID: 41147081 RESULT

• Le Blanc K, Frassoni F, Ball L, Locatelli F, Roelofs H, Lewis I, Lanino E, Sundberg B, Bernardo ME, Remberger M, Dini G, Egeler RM, Bacigalupo A, Fibbe W, Ringden O; Developmental Committee of the European Group for Blood and Marrow Transplantation. Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study. Lancet. 2008 May 10;371(9624):1579-86. doi: 10.1016/S0140-6736(08)60690-X.

  PMID: 18468541 RESULT

• Sonis ST. The pathobiology of mucositis. Nat Rev Cancer. 2004 Apr;4(4):277-84. doi: 10.1038/nrc1318. No abstract available.

  PMID: 15057287 RESULT

MeSH Terms

Conditions

Stomatitis; Mucositis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• xiaojin Wu, Principal Investigator

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

depei Wu Study Coordinator

CONTACT

+86-512-67972861; sdfyec@163.com

xiaojin Wu

CONTACT

281338205@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm (single group assignment), open-label, exploratory study. All enrolled participants receive the same intervention.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 10, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-02

Locations

CN (1)