MucositisMSC-MucInjNCT06599346
Effects of Mesenchymal Stem Cell Supernatant on Prevention and Treatment of Skin/Mucosal Injury in Hematology Patients
A study of Mucositis and Hematopoietic Stem Cell Transplantation, run by The General Hospital of Western Theater Command at 1 site in China.
Trial summary
This clinical trial is studying the effects of mesenchymal stem cell (MSC) culture supernatant on the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a common treatment for blood-related cancers and other serious blood disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis, Hematopoietic Stem Cell Transplantation, Chemotherapy-Induced Mucositis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 years or older.
- Patients who have undergone hematopoietic stem cell transplantation (HSCT).
- Patients who have developed mucosal injuries (oral, skin, or bladder) after HSCT, chemotherapy, or radiotherapy.
- Patients who are willing to provide informed consent and comply with the study procedures.
Who cannot join
- Patients with severe organ dysfunction (e.g., heart, liver, kidney failure) that could interfere with the study.
- Patients with uncontrolled active infections.
- Known allergies or hypersensitivity to MSC supernatant.
- Pregnant or breastfeeding women.
- Patients with HIV or active hepatitis B or C infections.
- Patients who have participated in another clinical trial within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, The General Hospital of Western Theater Command
Chengdu, Sichuan, 610083
Hao Yao, Ph.D, +86028571286, yaohao9001@163.com
Dan Chen, Bachelor, +86028571282, chendan286@163.com
About this study
Official title: Study on the Effects of Mesenchymal Stem Cell Culture Supernatant on the Prevention and Treatment of Mucosal Injury in Hematology Patients
This clinical trial is studying the effects of mesenchymal stem cell (MSC) culture supernatant on the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a common treatment for blood-related cancers and other serious blood disorders. However, many patients experience severe damage to their mucous membranes, including the lining of the mouth, skin, and bladder, due to the high-dose chemotherapy used in the treatment process. These mucosal injuries can cause pain, increase the risk of infection, and lower the patient's quality of life.
The purpose of this study is to determine whether MSC culture supernatant can help repair mucosal injuries and improve recovery for these patients. MSC culture supernatant contains substances produced by mesenchymal stem cells that may promote healing and reduce inflammation. These substances could potentially repair tissue without the risks associated with using live cells.
Read more
Participants in this trial will be randomly assigned to one of two groups: one group will receive standard care, and the other will receive MSC culture supernatant as part of their treatment. The study will look at how well MSC supernatant helps heal mucosal injuries, as well as its safety and any side effects that may occur. The outcomes of this study could lead to new ways to prevent and treat mucosal injuries in patients undergoing HSCT, improving their quality of life during and after treatment.
The trial will include 120 patients who have undergone HSCT and experienced mucosal injuries. The study will last approximately five years, from October 2020 to September 2025. Participants will be monitored throughout the trial for safety and effectiveness of the treatment, with follow-up visits scheduled to assess their progress.
Read the detailed description
This clinical trial aims to evaluate the efficacy and safety of mesenchymal stem cell (MSC) culture supernatant in the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a critical therapy for blood-related cancers and severe hematological disorders but is often associated with significant mucosal injuries caused by the high-dose chemotherapy and radiation therapy used during the preconditioning phase. These injuries predominantly affect the oral mucosa, skin, and bladder, resulting in severe pain, elevated infection risks, and prolonged hospitalization.
Current treatment options for mucosal injuries focus on symptom management but provide limited efficacy in accelerating tissue repair or preventing further complications. MSC culture supernatant contains a variety of bioactive factors, including growth factors and cytokines secreted by MSCs during culture. These factors are believed to promote tissue repair and regeneration, offering a promising alternative to live cell therapies, which pose higher safety risks. This study investigates MSC supernatant as a novel therapeutic option for mucosal injuries in HSCT patients.
Study Design:
This is a prospective, randomized controlled trial with a target enrollment of 120 patients. Participants will be randomly assigned to one of two groups:
Control Group: Patients will receive standard care for mucosal injuries, which may include oral rinses, pain management, and supportive care.
Intervention Group: Patients will receive MSC culture supernatant in addition to standard care. The MSC supernatant will be administered based on the type of mucosal injury:
Oral Mucosal Injuries: 15 mL of MSC supernatant will be used as a mouthwash. Skin Mucosal Injuries: MSC supernatant will be applied topically, proportional to the affected body surface area.
Bladder Injuries (Cystitis): 50 mL of MSC supernatant will be used for bladder irrigation.
Study Objectives:
Primary Objective: To assess the efficacy of MSC culture supernatant in the healing of mucosal injuries in HSCT patients. Mucosal healing will be evaluated using standardized scales such as the WHO mucosal injury scale and patient-reported pain scores.
Secondary Objective: To determine the safety and tolerability of MSC supernatant by monitoring adverse events (AEs) and serious adverse events (SAEs) in accordance with the CTCAE v5.0 criteria.
Exploratory Objectives: To explore the impact of MSC supernatant on tissue repair, infection reduction, length of hospital stay, and patient quality of life (QoL) during recovery from HSCT.
Inclusion and Exclusion Criteria:
Inclusion Criteria:
Patients who have undergone HSCT and developed mucosal injuries (oral, skin, or bladder).
Ability to understand and provide informed consent, and comply with study requirements.
Exclusion Criteria:
Patients with severe organ dysfunction or uncontrolled active infections. Patients with known allergies to MSC supernatant. Pregnant or breastfeeding women. Patients who are HIV-positive or have active hepatitis B or C. Patients enrolled in another clinical trial within the last four weeks.
Outcome Measures:
Primary Outcome: Mucosal injury healing, defined as a reduction in the mucosal injury grade to ≤1 and a pain score of ≤2.
Secondary Outcomes: Frequency and severity of adverse events related to MSC supernatant, measured according to CTCAE v5.0.
Exploratory Outcomes: Reduction in infection rates, shortened hospital stays, and improved patient-reported quality of life (QoL).
Monitoring and Safety:
Participants will undergo regular evaluations, including weekly assessments during the treatment phase and monthly follow-ups post-treatment. Laboratory tests (e.g., blood counts, liver and kidney function tests) and vital signs will be closely monitored to ensure patient safety. Adverse events will be documented, and appropriate interventions will be implemented as required.
It is important to note that while no Data Monitoring Committee (DMC) has been established for this study, safety oversight will be conducted by the research team following standard safety monitoring protocols.
Study Duration:
The trial is set to run from October 2020 to September 2025, with data collection for the primary outcomes expected to be completed by September 2025. Participants will be followed for the entirety of the study period, and long-term assessments will be conducted to evaluate the sustained efficacy and safety of MSC supernatant for mucosal injuries.
Significance:
This trial has the potential to introduce an innovative treatment strategy for managing mucosal injuries in HSCT patients. By utilizing the bioactive components of MSC culture supernatant, this therapy may enhance tissue regeneration, lower infection risk, and expedite recovery. If proven effective, this treatment could significantly improve patient outcomes and overall quality of life during and after HSCT.
- Conditions
- Mucositis, Hematopoietic Stem Cell Transplantation, Chemotherapy-Induced Mucositis, Radiation-Induced Mucositis
- Being tested
- Standard Care, MSC Supernatant + Standard Care
- Keywords
- Mesenchymal Stem Cell Supernatant, Mesenchymal Stem Cell Exosomes, Mucosal Injury, Hematopoietic Stem Cell Transplantation, Chemotherapy, Radiotherapy, Oral Mucosal Injury, Skin Mucosal Injury, Bladder Injury, HSCT Complications, Tissue Regeneration, Mucosal Repair
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Participants in this arm will receive standard care for mucosal injuries, which may include oral rinses, topical treatments, and supportive care based on the type of injury.
MSC Supernatant + Standard CareBiological
Participants in this arm will receive MSC supernatant in addition to standard care. MSC supernatant will be administered as follows:
15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation)
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Standard Care for Mucositis | Active comparator | Participants in this arm will receive standard care for mucositis, which may include oral rinses, topical treatments, and supportive care. Standard care will be tailored based on the type and severity of the mucosal injury (oral, skin, or bladder). Receives: Other: Standard Care |
| Experimental: MSC Supernatant + Standard Care for Mucositis | Experimental | Participants in this arm will receive MSC supernatant in addition to standard care for mucositis. The MSC supernatant will be administered as follows:
15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation) Receives: Biological: MSC Supernatant + Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Injury Healing
The degree of mucosal injury healing will be assessed using the WHO Mucosal Injury Scale (World Health Organization Mucosal Injury Grading Scale) and a pain score measured by the Visual Analog Scale (VAS) for pain.
WHO Mucosal Injury Scale: This scale assesses mucosal injury severity. The grades range from 0 (no injury) to 4 (severe ulceration and bleeding). A lower score indicates better mucosal health.
Visual Analog Scale (VAS) for pain: This scale measures pain on a range of 0 (no pain) to 10 (worst pain imaginable). A lower score indicates less pain.
The outcome will measure the percentage of participants with WHO mucosal injury grades ≤1 and VAS pain scores ≤2, indicating mild or no injury and low pain.
Measured: 8 weeks after the start of treatment.
Secondary outcomes (2)
Mucosal Infection Rates
The number of participants developing secondary infections related to mucosal injuries (oral, skin, bladder) during the study period. This outcome will report infection rates as a percentage of participants.
Measured: From the start of treatment through 8 weeks post-treatment.
Hospital Stay Duration
The number of days participants remain hospitalized during the study will be tracked, with comparisons made between the control and intervention groups.
Measured: From the start of treatment until discharge, assessed up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in this study will be randomly assigned to one of two groups in parallel. The control group will receive standard care for mucosal injuries (such as oral rinses and supportive care), while the intervention group will receive MSC supernatant treatment in addition to standard care. The treatments will be administered concurrently, and both groups will be monitored for the duration of the study to assess the effectiveness and safety of MSC supernatant in healing mucosal injuries caused by HSCT, chemotherapy, and radiotherapy.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chendan, The General Hospital of Western Theater Command
- Investigators
- Dan Chen, Bachelor, Principal investigator, Department of Hematology, The General Hospital of Western Theater CommandHao Yao, Ph.D, Principal investigator, Department of Hematology, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599346
- Sponsor's protocol ID
- 2023EC4-ky008
- Acronym
- MSC-MucInj
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Mesenchymal Stem Cell Culture Supernatant on the Prevention and Treatment of Mucosal Injury in Hematology Patients
- ClinicalTrials.gov ID
- NCT06599346
- Acronym / sponsor ID
- MSC-MucInj / 2023EC4-ky008
- Conditions
- Mucositis, Hematopoietic Stem Cell Transplantation, Chemotherapy-Induced Mucositis, Radiation-Induced Mucositis
- Keywords
- Mesenchymal Stem Cell Supernatant, Mesenchymal Stem Cell Exosomes, Mucosal Injury, Hematopoietic Stem Cell Transplantation, Chemotherapy, Radiotherapy, Oral Mucosal Injury, Skin Mucosal Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (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 clinical trial is studying the effects of mesenchymal stem cell (MSC) culture supernatant on the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a common treatment for blood-related cancers and other serious blood disorders. However, many patients experience severe damage to their mucous membranes, including the lining of the mouth, skin, and bladder, due to the high-dose chemotherapy used in the treatment process. These mucosal injuries can cause pain, increase the risk of infection, and lower the patient's quality of life.
The purpose of this study is to determine whether MSC culture supernatant can help repair mucosal injuries and improve recovery for these patients. MSC culture supernatant contains substances produced by mesenchymal stem cells that may promote healing and reduce inflammation. These substances could potentially repair tissue without the risks associated with using live cells.
Participants in this trial will be randomly assigned to one of two groups: one group will receive standard care, and the other will receive MSC culture supernatant as part of their treatment. The study will look at how well MSC supernatant helps heal mucosal injuries, as well as its safety and any side effects that may occur. The outcomes of this study could lead to new ways to prevent and treat mucosal injuries in patients undergoing HSCT, improving their quality of life during and after treatment.
The trial will include 120 patients who have undergone HSCT and experienced mucosal injuries. The study will last approximately five years, from October 2020 to September 2025. Participants will be monitored throughout the trial for safety and effectiveness of the treatment, with follow-up visits scheduled to assess their progress.
Detailed description
This clinical trial aims to evaluate the efficacy and safety of mesenchymal stem cell (MSC) culture supernatant in the prevention and treatment of mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a critical therapy for blood-related cancers and severe hematological disorders but is often associated with significant mucosal injuries caused by the high-dose chemotherapy and radiation therapy used during the preconditioning phase. These injuries predominantly affect the oral mucosa, skin, and bladder, resulting in severe pain, elevated infection risks, and prolonged hospitalization.
Current treatment options for mucosal injuries focus on symptom management but provide limited efficacy in accelerating tissue repair or preventing further complications. MSC culture supernatant contains a variety of bioactive factors, including growth factors and cytokines secreted by MSCs during culture. These factors are believed to promote tissue repair and regeneration, offering a promising alternative to live cell therapies, which pose higher safety risks. This study investigates MSC supernatant as a novel therapeutic option for mucosal injuries in HSCT patients.
Study Design:
This is a prospective, randomized controlled trial with a target enrollment of 120 patients. Participants will be randomly assigned to one of two groups:
Control Group: Patients will receive standard care for mucosal injuries, which may include oral rinses, pain management, and supportive care.
Intervention Group: Patients will receive MSC culture supernatant in addition to standard care. The MSC supernatant will be administered based on the type of mucosal injury:
Oral Mucosal Injuries: 15 mL of MSC supernatant will be used as a mouthwash. Skin Mucosal Injuries: MSC supernatant will be applied topically, proportional to the affected body surface area.
Bladder Injuries (Cystitis): 50 mL of MSC supernatant will be used for bladder irrigation.
Study Objectives:
Primary Objective: To assess the efficacy of MSC culture supernatant in the healing of mucosal injuries in HSCT patients. Mucosal healing will be evaluated using standardized scales such as the WHO mucosal injury scale and patient-reported pain scores.
Secondary Objective: To determine the safety and tolerability of MSC supernatant by monitoring adverse events (AEs) and serious adverse events (SAEs) in accordance with the CTCAE v5.0 criteria.
Exploratory Objectives: To explore the impact of MSC supernatant on tissue repair, infection reduction, length of hospital stay, and patient quality of life (QoL) during recovery from HSCT.
Inclusion and Exclusion Criteria:
Inclusion Criteria:
Patients who have undergone HSCT and developed mucosal injuries (oral, skin, or bladder).
Ability to understand and provide informed consent, and comply with study requirements.
Exclusion Criteria:
Patients with severe organ dysfunction or uncontrolled active infections. Patients with known allergies to MSC supernatant. Pregnant or breastfeeding women. Patients who are HIV-positive or have active hepatitis B or C. Patients enrolled in another clinical trial within the last four weeks.
Outcome Measures:
Primary Outcome: Mucosal injury healing, defined as a reduction in the mucosal injury grade to ≤1 and a pain score of ≤2.
Secondary Outcomes: Frequency and severity of adverse events related to MSC supernatant, measured according to CTCAE v5.0.
Exploratory Outcomes: Reduction in infection rates, shortened hospital stays, and improved patient-reported quality of life (QoL).
Monitoring and Safety:
Participants will undergo regular evaluations, including weekly assessments during the treatment phase and monthly follow-ups post-treatment. Laboratory tests (e.g., blood counts, liver and kidney function tests) and vital signs will be closely monitored to ensure patient safety. Adverse events will be documented, and appropriate interventions will be implemented as required.
It is important to note that while no Data Monitoring Committee (DMC) has been established for this study, safety oversight will be conducted by the research team following standard safety monitoring protocols.
Study Duration:
The trial is set to run from October 2020 to September 2025, with data collection for the primary outcomes expected to be completed by September 2025. Participants will be followed for the entirety of the study period, and long-term assessments will be conducted to evaluate the sustained efficacy and safety of MSC supernatant for mucosal injuries.
Significance:
This trial has the potential to introduce an innovative treatment strategy for managing mucosal injuries in HSCT patients. By utilizing the bioactive components of MSC culture supernatant, this therapy may enhance tissue regeneration, lower infection risk, and expedite recovery. If proven effective, this treatment could significantly improve patient outcomes and overall quality of life during and after HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in this study will be randomly assigned to one of two groups in parallel. The control group will receive standard care for mucosal injuries (such as oral rinses and supportive care), while the intervention group will receive MSC supernatant treatment in addition to standard care. The treatments will be administered concurrently, and both groups will be monitored for the duration of the study to assess the effectiveness and safety of MSC supernatant in healing mucosal injuries caused by HSCT, chemotherapy, and radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Standard Care for Mucositis | Active comparator | Other: Standard CareParticipants in this arm will receive standard care for mucositis, which may include oral rinses, topical treatments, and supportive care. Standard care will be tailored based on the type and severity of the mucosal injury (oral, skin, or bladder). |
| Experimental: MSC Supernatant + Standard Care for Mucositis | Experimental | Biological: MSC Supernatant + Standard CareParticipants in this arm will receive MSC supernatant in addition to standard care for mucositis. The MSC supernatant will be administered as follows: 15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 years or older.
- Patients who have undergone hematopoietic stem cell transplantation (HSCT).
- Patients who have developed mucosal injuries (oral, skin, or bladder) after HSCT, chemotherapy, or radiotherapy.
- Patients who are willing to provide informed consent and comply with the study procedures.
Key exclusion criteria (6 listed)
- Patients with severe organ dysfunction (e.g., heart, liver, kidney failure) that could interfere with the study.
- Patients with uncontrolled active infections.
- Known allergies or hypersensitivity to MSC supernatant.
- Pregnant or breastfeeding women.
- Patients with HIV or active hepatitis B or C infections.
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 |
|---|---|---|
| Standard CareParticipants in this arm will receive standard care for mucosal injuries, which may include oral rinses, topical treatments, and supportive care based on the type of injury. | Other | Active Comparator: Standard Care for Mucositis |
| MSC Supernatant + Standard CareParticipants in this arm will receive MSC supernatant in addition to standard care. MSC supernatant will be administered as follows: 15 mL for oral mucosal injuries (mouthwash) Topical application for skin mucosal injuries (based on body surface area) 50 mL for bladder injuries (bladder irrigation) | Biological | Experimental: MSC Supernatant + Standard Care for Mucositis |
Primary outcome
Mucosal Injury Healing
Time frame: 8 weeks after the start of treatment.
The degree of mucosal injury healing will be assessed using the WHO Mucosal Injury Scale (World Health Organization Mucosal Injury Grading Scale) and a pain score measured by the Visual Analog Scale (VAS) for pain. WHO Mucosal Injury Scale: This scale assesses mucosal injury severity. The grades range from 0 (no injury) to 4 (severe ulceration and bleeding). A lower score indicates better mucosal health. Visual Analog Scale (VAS) for pain: This scale measures pain on a range of 0 (no pain) to 10 (worst pain imaginable). A lower score indicates less pain. The outcome will measure the percentage of participants with WHO mucosal injury grades ≤1 and VAS pain scores ≤2, indicating mild or no injury and low pain.
2 secondary outcomes
Mucosal Infection Rates
Time frame: From the start of treatment through 8 weeks post-treatment.
Hospital Stay Duration
Time frame: From the start of treatment until discharge, assessed up to 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dan Chen, Bachelor principal investigator
Department of Hematology, The General Hospital of Western Theater Command
Hao Yao, Ph.D principal investigator
Department of Hematology, The General Hospital of Western Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mucositis and Hematopoietic Stem Cell Transplantation, run by The General Hospital of Western Theater Command 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Yao, Ph.D (+86-028-86571286, yaohao9001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal Injury Healing (time frame: 8 weeks after the start of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.