Dental Medullary Mesenchymal Stem Cells in Treatment of Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT03658655|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes||Biological: Dental pulp mesenchymal stem cells||Early Phase 1|
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: pulp mesenchymal stem cells were calculated at 0.1IU/kg body weight . Course of treatment: 3 times, respectively at the time of enrollment, 1 week after enrollment and 4 weeks after enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open, One-arm, Single-center Clinical Study to Evaluate the Efficacy and Safety of Dental Medullary Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Dental pulp mesenchymal stem cells
According to the weight of 0.1IU /kg with Dental pulp mesenchymal stem cells, three injections will be given respectively at the time of enrollment, one week and four weeks after enrollment.
Biological: Dental pulp mesenchymal stem cells
The original treatment regimen will be 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, but patients still had frequent hypoglycemia).
Stem cell therapy:
Usage: drip slowly, 50ml normal saline first, then pulp mesenchymal stem cells (during 60 min), then 50ml normal saline.
- Total daily insulin [ Time Frame: 1 week ]After treatment total daily insulin dose changes
- HbAlc [ Time Frame: 1 week ]The proportion of patients with HbA1c < 7.0% and < 6.5%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658655
|Contact: Qin Huang, Doctoremail@example.com|
|Contact: Jingyun Song||86-13795368981|
|Shanghai, Shanghai, China|
|Contact: Qin Huang, Doctor +86 13818333125 firstname.lastname@example.org|
|Principal Investigator:||Qin Huang, Doctor||Changhai houspital|