- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- 1. korai fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Qin Huang, Doctor
- Telefonszám: 13818333125
- E-mail: qxinyi1220@163.com
Tanulmányi helyek
-
-
Shanghai
-
Shanghai, Shanghai, Kína
- Toborzás
- Changhai Hospital
-
Kapcsolatba lépni:
- Qin Huang, Doctor
- Telefonszám: +86 13818333125
- E-mail: qxinyi1220@163.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: 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
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Total daily insulin dose
Időkeret: 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
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Islet function
Időkeret: 1 year
|
c-peptide and proinsulin
|
1 year
|
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia
Időkeret: 1 year
|
Changes relative to baseline during treatment
|
1 year
|
Continuous dynamic blood glucose
Időkeret: 1 year
|
Changes relative to baseline during treatment
|
1 year
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Qin Huang, Doctor, Changhai houspital
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- KTLC002
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .