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To evaluate the safety and efficacy of Stem cells from human exfoliated teeth transplantation in patients with Islet function decreased significantly to provides scientific basis for further clinical studies to verify the safety and efficacy. On the basis of maintaining the original treatment, intravenous drip of dental pulp mesenchymal stem cells.
Basic treatment:
The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia).
Stem cell therapy:
Dosage: Stem cells from human exfoliated teeth were calculated at 0.11IU/kg body weight .
Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment.
Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cells from human exfoliated teeth | Experimental | Basic treatment: The original treatment regimen was maintained. During the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped or patients still had frequent hypoglycemia). Stem cell therapy: Dosage: Stem cells from human exfoliated teeth were calculated at 0.11IU/kg body weight . Course of treatment: 3 times, Injections were administered at enrollment, 2 weeks after enrollment, and 6 weeks after enrollment. Note: at 1 month follow-up (V5) after the last transplantation of several cells, the subjects were still unable to discontinue insulin, and then began the second course of stem cell therapy.After the second course of treatment, the follow-up plan was resumed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cells from human exfoliated teeth | Biological | Intravenous infusion of pulp mesenchymal stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total daily insulin dose | change from baseline during treatment | baseline and 1,2,6 week and 2,3,6,9,12 month |
| glucose-c peptide release test | relative baseline change during treatment | baseline and 1,2,6 week and 2,3,6,9,12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Islet function | c-peptide and proinsulin | 1 year |
| Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia | Changes relative to baseline during treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Huang, Doctor | Contact | 13818333125 | qxinyi1220@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Huang, Doctor | Changhai houspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| 1 year |
| Continuous dynamic blood glucose | Changes relative to baseline during treatment | 1 year |