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

18. april 2019 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

24

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Shanghai
      • Shanghai, Shanghai, Kina
        • Rekruttering
        • Changhai Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total daily insulin dose
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Islet function
Tidsramme: 1 year
c-peptide and proinsulin
1 year
Composite index of glycosylated hemoglobin (HbAlc) and frequency of hypoglycemia
Tidsramme: 1 year
Changes relative to baseline during treatment
1 year
Continuous dynamic blood glucose
Tidsramme: 1 year
Changes relative to baseline during treatment
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Qin Huang, Doctor, Changhai houspital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. januar 2019

Primær færdiggørelse (Forventet)

30. december 2020

Studieafslutning (Forventet)

31. marts 2021

Datoer for studieregistrering

Først indsendt

10. april 2019

Først indsendt, der opfyldte QC-kriterier

10. april 2019

Først opslået (Faktiske)

11. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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