Using stem cells to treat radiation-induced rectal injury
A Study on the Efficacy and Safety of Endoscopic Local Injection of Umbilical Cord Mesenchymal Stem Cells（TH-SC01） for the Treatment of Radiation-induced Rectal Injury.
This study is testing whether a new stem cell treatment can help people with radiation-induced rectal injury feel better and heal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05939778 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of allogeneic umbilical cord mesenchymal stem cells for patients suffering from radiation-induced rectal injury (RRI). RRI is a significant condition that can lead to severe complications and negatively impact patients' quality of life. The trial aims to provide a new treatment option for chronic RRI, which currently lacks standardized effective therapies. Participants will receive TH-SC01, the stem cell treatment, to assess its potential benefits in alleviating symptoms and promoting healing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with chronic radiation rectal injury and in good physical condition.
Not a fit: Patients with severe liver or kidney disease, active gastrointestinal hemorrhage, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic radiation-induced rectal injury.
How similar studies have performed: There have been few clinical studies on mesenchymal stem cells for this condition, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Fully understand and sign the informed consent form; 2. Age ≥18 years and \<80 years; 3. Patients diagnosed with chronic radiation rectal injury after radiation therapy; 4. Patients with LENT-SOMA scale score ≥1; 5. Good physical condition (WHO functional status score 0-1). Exclusion Criteria: 1. The patient had severe liver and kidney disease; 2. Severe congestive heart failure or coronary heart disease; 3. Patients have allergic constitutions or severe systemic immune diseases; 4. The patient had active gastrointestinal hemorrhage or acute intestinal obstruction; 5. Patients were pregnant or had other conditions that the investigators deemed unsuitable for inclusion in the study.
Where this trial is running
Nanjing, Jiangsu
- Jinling Hospital, China — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Fangyu Wang
- Email: quanguorenmin1994@163.com
- Phone: 0086-13515100636
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.