Oral MucositisPhase 2NCT07400328
Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
A Phase 2 study testing Amimestrocel injection in people with Oral Mucositis and Stomatitis, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Mucositis, Stomatitis, Gastrointestinal Mucositis
- What is being tested?
- Amimestrocel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2026to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
xiaojin Wu contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, 215006
xiaojin wu, 86+051267976360, wuxiaojin@suda.edu.cn
About this study
Official title: A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and/or Melphalan
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.
Read more
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.
Read the detailed description
Background and Rationale:
Myeloablative conditioning regimens containing total body irradiation (TBI) and/or high-dose melphalan are standard prior to allogeneic hematopoietic stem cell transplantation (HSCT) but frequently cause severe gastrointestinal mucositis. This condition leads to significant morbidity, including pain, dysphagia, diarrhea, nutritional impairment, infection risk, prolonged hospitalization, and increased costs. Effective preventive strategies are limited. Mesenchymal stem cells (MSCs) have demonstrated immunomodulatory and tissue-repair properties via paracrine secretion of anti-inflammatory and growth factors, showing potential in mitigating mucosal injury in preclinical and early clinical contexts.
Study Design:
This is a single-arm, single-center, open-label, exploratory interventional study. It will enroll approximately 22 subjects to preliminarily evaluate the efficacy and safety of prophylactic Amimestrocel infusion.
Intervention:
Eligible patients will receive a single, fixed-dose intravenous infusion of Amimestrocel injection (6.0×10⁷ cells in 150 mL) 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).
Study Population:
Adults aged 18-65 years planned for myeloablative allogeneic HSCT with a TBI and/or melphalan-containing conditioning regimen, with adequate organ function and ECOG status 0-1. Key exclusions include active uncontrolled infection, allergy to MSCs, prior cell therapy, and pregnancy.
Endpoints and Assessments:
Primary Endpoint: Incidence of Grade 3-4 oral mucositis (assessed daily by WHO/NCI-CTCAE criteria) within 28 days post-transplant (Day 0 to +28).
Secondary Endpoints: Duration/severity of oral and gastrointestinal mucositis; oral pain (Numerical Rating Scale); opioid use; time to neutrophil engraftment (ANC ≥0.5×10⁹/L); incidence of adverse events and serious adverse events (monitored until Day +100).
Sample Size Justification:
The sample size of 22 is derived from an assumption of reducing the historical incidence of severe oral mucositis (71% based on literature) to 41% (30% absolute reduction), with 80% power and a two-sided alpha of 0.05, accounting for a 10% dropout rate.
Study Procedures Overview:
The process includes a screening period (Day -14 to -7), the investigational product infusion, an intensive observation phase (Day 0 to +28) with daily mucositis and pain assessments, and a safety follow-up phase until Day +100 for AE/SAE monitoring, GVHD, and survival status.
- Conditions
- Oral Mucositis, Stomatitis, Gastrointestinal Mucositis, Hematopoietic Stem Cell Transplantation
- Being tested
- Amimestrocel injection
- Keywords
- Amimestrocel, Mesenchymal Stem Cells, Umbilical Cord, Mucositis Prevention, Total Body Irradiation, Melphalan, Conditioning Regimen, Allogeneic Transplantation, Single-Arm Trial
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amimestrocel injectionBiological
Also called Ruibo Sheng
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Amimestrocel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From stem cell infusion (Day 0) up to Day 28 post-transplant
Secondary outcomes (9)
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.
Measured: From Day 0 up to Day 28 post-transplant.
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.
Measured: From Day 0 up to Day 28 post-transplant.
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.
Measured: From Day 0 up to Day 28 post-transplant.
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.
Measured: 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.
Measured: 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.
Total Opioid Use from Day 0 to Day 28 Post-Transplant
The total consumption of opioids for controlling oral mucositis-related pain from Day 0 to Day 28 post-transplant, converted to oral morphine milligram equivalents (MME). Results are described as median and interquartile range.
Measured: From Day 0 up to Day 28 post-transplant.
Time to Neutrophil Engraftment
The number of days from Day 0 to the first of three consecutive days with an absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L. Estimated using the Kaplan-Meier method.
Measured: From Day 0 up to Day 60 post-transplant.
Incidence of Any Adverse Event (AE) within 100 Days Post-Transplant
The proportion of subjects who experience any grade of adverse event (AE) from after the investigational product infusion up to Day 100 post-transplant. The severity and relationship to the investigational product are assessed according to NCI CTCAE v5.0 criteria and protocol specifications.
Measured: From after investigational product infusion up to Day 100 post-transplant.
Incidence of Serious Adverse Events (SAEs) within 100 Days Post-Transplant
The proportion of subjects who experience any serious adverse event (SAE) from after the investigational product infusion up to Day 100 post-transplant. SAE definition follows ICH-GCP guidelines.
Measured: From after investigational product infusion up to Day 100 post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start15 Feb 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm (single group assignment), open-label, exploratory study. All enrolled participants receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaojin Wu, Principal Investigator, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400328
- Sponsor's protocol ID
- SOOCHOW-WXJ-2025-1292
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36008731Kebriaei 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.
PubMed 31505228Lv 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.
PubMed 41147081Le 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.
PubMed 18468541Sonis ST. The pathobiology of mucositis. Nat Rev Cancer. 2004 Apr;4(4):277-84. doi: 10.1038/nrc1318. No abstract available.
PubMed 15057287
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center Exploratory Study of Amimestrocel Injection for the Prevention of Gastrointestinal Mucositis Induced by Conditioning Regimens Containing TBI and/or Melphalan
- ClinicalTrials.gov ID
- NCT07400328
- Acronym / sponsor ID
- SOOCHOW-WXJ-2025-1292
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Myeloablative conditioning regimens containing total body irradiation (TBI) and/or high-dose melphalan are standard prior to allogeneic hematopoietic stem cell transplantation (HSCT) but frequently cause severe gastrointestinal mucositis. This condition leads to significant morbidity, including pain, dysphagia, diarrhea, nutritional impairment, infection risk, prolonged hospitalization, and increased costs. Effective preventive strategies are limited. Mesenchymal stem cells (MSCs) have demonstrated immunomodulatory and tissue-repair properties via paracrine secretion of anti-inflammatory and growth factors, showing potential in mitigating mucosal injury in preclinical and early clinical contexts.
Study Design:
This is a single-arm, single-center, open-label, exploratory interventional study. It will enroll approximately 22 subjects to preliminarily evaluate the efficacy and safety of prophylactic Amimestrocel infusion.
Intervention:
Eligible patients will receive a single, fixed-dose intravenous infusion of Amimestrocel injection (6.0×10⁷ cells in 150 mL) 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).
Study Population:
Adults aged 18-65 years planned for myeloablative allogeneic HSCT with a TBI and/or melphalan-containing conditioning regimen, with adequate organ function and ECOG status 0-1. Key exclusions include active uncontrolled infection, allergy to MSCs, prior cell therapy, and pregnancy.
Endpoints and Assessments:
Primary Endpoint: Incidence of Grade 3-4 oral mucositis (assessed daily by WHO/NCI-CTCAE criteria) within 28 days post-transplant (Day 0 to +28).
Secondary Endpoints: Duration/severity of oral and gastrointestinal mucositis; oral pain (Numerical Rating Scale); opioid use; time to neutrophil engraftment (ANC ≥0.5×10⁹/L); incidence of adverse events and serious adverse events (monitored until Day +100).
Sample Size Justification:
The sample size of 22 is derived from an assumption of reducing the historical incidence of severe oral mucositis (71% based on literature) to 41% (30% absolute reduction), with 80% power and a two-sided alpha of 0.05, accounting for a 10% dropout rate.
Study Procedures Overview:
The process includes a screening period (Day -14 to -7), the investigational product infusion, an intensive observation phase (Day 0 to +28) with daily mucositis and pain assessments, and a safety follow-up phase until Day +100 for AE/SAE monitoring, GVHD, and survival status.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm (single group assignment), open-label, exploratory study. All enrolled participants receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Amimestrocel Injection | Experimental | Biological: Amimestrocel injectionAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amimestrocel injectionAlso: Ruibo ShengAmimestrocel 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. | Biological | Amimestrocel Injection |
Primary outcome
Incidence of Grade 3-4 Oral Mucositis within 28 Days Post-Transplant
Time frame: From stem cell infusion (Day 0) up to Day 28 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.
9 secondary outcomes
Maximum Severity Grade of Oral Mucositis
Time frame: From Day 0 up to Day 28 post-transplant.
Duration of Oral Mucositis
Time frame: From Day 0 up to Day 28 post-transplant.
Maximum Severity Grade of Diarrhea
Time frame: From Day 0 up to Day 28 post-transplant.
Total Duration of ≥ Grade 2 Diarrhea
Time frame: From Day 0 up to Day 28 post-transplant.
Peak Oral Pain Score
Time frame: 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.
Total Opioid Use from Day 0 to Day 28 Post-Transplant
Time frame: From Day 0 up to Day 28 post-transplant.
Time to Neutrophil Engraftment
Time frame: From Day 0 up to Day 60 post-transplant.
Incidence of Any Adverse Event (AE) within 100 Days Post-Transplant
Time frame: From after investigational product infusion up to Day 100 post-transplant.
Incidence of Serious Adverse Events (SAEs) within 100 Days Post-Transplant
Time frame: From after investigational product infusion up to Day 100 post-transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 36008731Nakagaki 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.
- Background: PubMed 31505228Kebriaei 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.
- Results publication: PubMed 41147081Lv 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.
- Results publication: PubMed 18468541Le 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.
- Results publication: PubMed 15057287Sonis ST. The pathobiology of mucositis. Nat Rev Cancer. 2004 Apr;4(4):277-84. doi: 10.1038/nrc1318. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
xiaojin Wu contact
xiaojin Wu, Principal Investigator principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amimestrocel injection in people with Oral Mucositis and Stomatitis, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact depei Wu Study Coordinator (+86-512-67972861, sdfyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3-4 Oral Mucositis within 28 Days Post-Transplant (time frame: From stem cell infusion (Day 0) up to Day 28 post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07400328, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.