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Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function

18 april 2019 bijgewerkt door: CAR-T (Shanghai) Biotechnology Co., Ltd.

Study on the Efficacy and Safety of Stem Cells From Human Exfoliated Teeth in Treating Diabetic Patients With Significantly Reduced Islet Function

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.

Studie Overzicht

Toestand

Onbekend

Conditie

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

Ingrijpend

Inschrijving (Verwacht)

24

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Shanghai
      • Shanghai, Shanghai, China
        • Werving
        • Changhai Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Understand the purpose of clinical trials, willing to participate and sign informed consent;
  2. 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;
  3. Islet function test (steamed bread test) : c-peptide fasting 1ng/ml, 2 hours 2ng/ml
  4. 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.
  5. Age 25-70 years old, gender not limited;
  6. Body mass index (BMI) : between 19 and 28kg/m2;
  7. 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:

  1. Patients with gestational diabetes or other special types of diabetes;
  2. Acute complications such as diabetic ketoacidosis and non-ketotic hyperosmolar syndrome were screened within the first month;
  3. Patients who have received other stem cell therapy before screening;
  4. Blood pressure of patients with poor blood pressure control: 160/100mmhg at the time of screening;
  5. Those who took thiazolidinediones, ddp-iv inhibitors and glp-1 drugs within the first 3 months were screened;
  6. 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;
  7. Patients with pancreatic diseases, including those with acute and chronic pancreatitis and pancreatic tumors;
  8. 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;
  9. 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);
  10. 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;
  11. Is on systemic sex hormone (glucocorticoid), immunosuppressant or cytotoxic therapy;
  12. 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;
  13. Patients with contraindications or allergies treated in this study;
  14. Subjects who have participated in other clinical studies in the past 3 months.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

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

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Qin Huang, Doctor, Changhai houspital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 januari 2019

Primaire voltooiing (Verwacht)

30 december 2020

Studie voltooiing (Verwacht)

31 maart 2021

Studieregistratiedata

Eerst ingediend

10 april 2019

Eerst ingediend dat voldeed aan de QC-criteria

10 april 2019

Eerst geplaatst (Werkelijk)

11 april 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 april 2019

Laatste update ingediend die voldeed aan QC-criteria

18 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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