Using stem cell products to treat mucosal injuries in blood cancer patients
Study on the Effects of Mesenchymal Stem Cell Culture Supernatant on the Prevention and Treatment of Mucosal Injury in Hematology Patients
NA · The General Hospital of Western Theater Command · NCT06599346
This study is testing if a special treatment made from stem cells can help blood cancer patients recover from mouth and throat injuries caused by their cancer treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The General Hospital of Western Theater Command (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06599346 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of mesenchymal stem cell (MSC) culture supernatant in preventing and treating mucosal injuries in patients undergoing hematopoietic stem cell transplantation (HSCT). HSCT is a vital treatment for blood-related cancers, but it often leads to severe mucosal damage due to high-dose chemotherapy and radiation. The study aims to determine if MSC supernatant, which contains healing substances produced by stem cells, can enhance recovery and reduce inflammation associated with these injuries. Participants will be randomly assigned to receive either standard care or MSC supernatant combined with standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone HSCT and developed mucosal injuries due to treatment.
Not a fit: Patients with severe organ dysfunction, uncontrolled infections, or specific allergies to MSC supernatant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and quality of life for patients suffering from mucosal injuries after HSCT.
How similar studies have performed: While the use of MSC supernatant is a novel approach, similar studies involving stem cell therapies have shown promising results in tissue repair.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Chengdu, Sichuan
- Department of Hematology, The General Hospital of Western Theater Command — Chengdu, Sichuan, China (RECRUITING)
Study contacts
- Principal investigator: Dan Chen, Bachelor — Department of Hematology, The General Hospital of Western Theater Command
- Study coordinator: Hao Yao, Ph.D
- Email: yaohao9001@163.com
- Phone: +86-028-86571286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mucositis, Hematopoietic Stem Cell Transplantation, Chemotherapy-Induced Mucositis, Radiation-Induced Mucositis, Mesenchymal Stem Cell Supernatant, Mesenchymal Stem Cell Exosomes, Mucosal Injury, Chemotherapy