Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599346
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Effects of Mesenchymal Stem Cell Supernatant on Prevention and Treatment of SkinMucosal Injury in Hematology Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study on the Effects of Mesenchymal Stem Cell Culture Supernatant on the Prevention and Treatment of Mucosal Injury in Hematology Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSC-MucInj
Brief 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 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 patients 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
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 v50 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 v50
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 eg 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
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 v50 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 v50
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None