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- Klinische proef NCT03912480
Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function
Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Vroege fase 1
Contacten en locaties
Studiecontact
- Naam: Qin Huang, Doctor
- Telefoonnummer: 13818333125
- E-mail: qxinyi1220@163.com
Studie Locaties
-
-
Shanghai
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Shanghai, Shanghai, China
- Werving
- Changhai Hospital
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Contact:
- Qin Huang, Doctor
- Telefoonnummer: +86 13818333125
- E-mail: qxinyi1220@163.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Understand the purpose of clinical trials, willing to participate and sign informed consent;
- Patients with type 2 diabetes are clearly diagnosed according to WHO diagnostic criteria and whose disease duration is more than 5 years, or whose disease duration of type 1 diabetes is more than 1 year;
- Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
- Insulin (with or without oral hypoglycemic therapy) and fasting blood glucose (FPG)9.0mmol/L, HbAlc 8.5; The service life of oral hypoglycemic drugs (including metformin, alpha-glucosidase inhibitors or insulin secreting agents) was more than 3 months.
- Age 25-70 years old, gender not limited;
- Body mass index (BMI) : between 19 and 28kg/m2;
- from the date of screening to the end of follow-up, male or female subjects of childbearing age will voluntarily take precautions Pregnancy; Urine pregnancy test was negative when screening women of childbearing age, and serum pregnancy test was performed when necessary to clearly exclude pregnancy.-
Exclusion Criteria:
- Patients with gestational diabetes or other special types of diabetes;
- Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
- Patients who have received other stem cell therapy before screening;
- Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
- Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
- Patients who have used insulin for less than 1 year before screening and only injected insulin subcutaneously once a day within the past 3 months;
- Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
- Patients with other malignant tumors or suspected tumor tendency;Or in the active phase of various infections (including active stage of HBV or HCV infection);Immunodeficiency virus (HIV) positive patients;
- Patients with other serious systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, immune system and blood system);
- For patients with liver and kidney dysfunction, for example, serum bilirubin TBIL exceeds 1.5 times of the normal upper limit, AST and ALT exceed 2.5 times of the normal upper limit, and serum creatinine Cr exceeds 1.2 times of the normal upper limit;
- Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy;
- Disabled patients (blind, deaf, dumb, mentally retarded, physically disabled) as stipulated by law, pregnant women and lactating women;People suffering from mental illness;Patients who take drugs or have a history of adverse drug abuse and alcohol dependence within 5 years;
- Patients with contraindications or allergies treated in this study;
- Subjects who have participated in other clinical studies in the past 3 months.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Stem cells from human exfoliated teeth
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. |
Intravenous infusion of pulp mesenchymal stem cells
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Total daily insulin dose
Tijdsspanne: baseline and 1,2,6 week and 2,3,6,9,12 month
|
change from baseline during treatment
|
baseline and 1,2,6 week and 2,3,6,9,12 month
|
glucose-c peptide release test
Tijdsspanne: baseline and 1,2,6 week and 2,3,6,9,12 month
|
relative baseline change during treatment
|
baseline and 1,2,6 week and 2,3,6,9,12 month
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Islet function
Tijdsspanne: 1 year
|
c-peptide and proinsulin
|
1 year
|
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia
Tijdsspanne: 1 year
|
Changes relative to baseline during treatment
|
1 year
|
Continuous dynamic blood glucose
Tijdsspanne: 1 year
|
Changes relative to baseline during treatment
|
1 year
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Qin Huang, Doctor, Changhai houspital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KTLC002
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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