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A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs treatment group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells (MSCs) | Drug | single dose injection (120 million cells) |
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| Measure | Description | Time Frame |
|---|---|---|
| Radioactive distribution | The radioactive distribution in the injection site and various organs or tissues after local injection in patients with radiation proctitis | 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events | All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12- ead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jueyu Xia, Master | Contact | 025-52700103 | xiajueyu@topcelbio.com |
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| Week1, Week 4, Week 24,Month 24 |
| Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement. | The clinical symptom assessment adopts the LENT-SOMA score, total score ranges from 0 to 4, higher score means more severe symptoms. The endoscopic evaluation adopts the Vienna Rectoscopy Score, The score range from 0 to 5 points. The highest score of each individual item is counted as the total VRS score. Higher the VRS score means more severe lesions. | Week 4,Week 24 |
| Radiation exposure | The uptake rate (%ID), absorbed dose and whole-body effective dose of important organs or tissues after local injection administration of [89Zr] human-derived TH-SC01 cell injection. | Week 1 |