A Phase 1/2 interventional study of Mesenchymal Stem Cells (MSCs) in Chronic Radiation Proctitis, sponsored by Jiangsu Topcel-KH Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment
A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.
Radiation therapy is frequently used to treat pelvic cancers such as anal, cervical, prostate, and rectal cancer. While effective in controlling local tumors, it can also cause collateral damage to the gastrointestinal tract. The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis. In the acute phase, radiation can lead to proctitis, an inflammatory condition characterized by mucosal ulceration, edema, and loss of microvilli. Patients typically present within three months of radiation therapy with symptoms like diarrhea, urgency, and tenesmus. Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period, typically 8 to 12 months post-radiation treatment. This chronic condition results from radiation-induced small-vessel injury, causing ischemia, obliterative endarteritis, fibrosis, and neovascularization. Rectal bleeding is a common symptom of chronic radiation proctitis.
Clinical studies have demonstrated that mesenchymal stem cell (MSC) treatment offers significant benefits, including anti-inflammatory, immune modulation, and tissue repair effects. Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis, reducing pain and bleeding without causing severe adverse events. This suggests that MSC treatment could be a promising option for radiation proctitis.
This is a phase I/II study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis. Patients will be followed up for 24 months after treatment.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
This study's planned enrollment of 24 is below the median of 122 across 23 interventional studies indexed under Proctitis.
Browse Proctitis studies →Jiangsu Topcel-KH Pharmaceutical Co., Ltd. is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months.
Biological: Mesenchymal Stem Cells (MSCs)
MSC suspension single does injection.
The severity of adverse events after administration as assessed by CTCAE v5.0.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
Time frame: 28 days (1 month)
The incidence of adverse events after administration.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
Time frame: 28 days (1 month)
The severity of adverse events after administration as assessed by CTCAE v5.0.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
Time frame: 112 days (4 month)
The incidence of adverse events after administration.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
Time frame: 112 days (4 month)
The recurrence of chronic radiation proctitis symptoms after administration.
The recurrence means that subjects who were previously cured or relieved are diagnosed again by the investigator, clinically, as having chronic radiation proctitis.
Time frame: Day 112 (month 4)
The deterioration of chronic radiation proctitis symptoms after administration.
The deterioration means that the symptoms of chronic radiation proctitis have worsened compared to baseline.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by LENT-SOMA score.
The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) is used for grading radiation therapy (RT)-induced side effects. It is graded on a 4-point scale ranging from occasional (score of 1) to refractory (score of 4), with a higher score indicating more severe disease. No improvement means no improvement of the score comparing to the baseline level.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by VRS.
The Vienna Rectoscopy Score (VRS) is a feasible and effective tool for detecting and classifying pathological changes in the rectal mucosa after radiotherapy (RT). It is graded on a 5-point scale, ranging from 0 to 5, with a higher score indicating more severe disease. No improvement means that the score does not improve compared to the baseline level.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by a semi-quantitative scoring system for radiotherapy-induced rectal pathological damage.
A specific scoring system that assesses the intensity of morphological features has been developed. The total score ranging from 0 to 10 , and a higher score indicates more severe disease. No improvement means that the score does not improve compared to the baseline level.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by a RTD grading scale.
The rectal telangiectasia density (RTD) grading scale ranges from 0 to 3, and a higher score indicates the disease is more severe. No improvement means that the score does not improve compared to the baseline level.
Time frame: Day 112 (month 4)
No improvement of chronic radiation proctitis symptoms after administration as assessed by VAS score.
The Visual Analogue Scale (VAS) is commonly used to assess the intensity of a patient's pain, ranging from none to extreme. It is graded on an 11-point scale,ranging from 0 to 10,with higher scores indicating more severe pain. No improvement means that the score does not improve compared to the baseline level.
Time frame: Day 112 (month 4)
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for May 2025, 12 months after the start.
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Jiangsu Topcel-KH Pharmaceutical Co., Ltd.