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Lo studio clinico NCT07495956 per Diabete Mellito di Tipo II è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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cfMSC Therapy for Diabetes Fase I, Fase II 30 Innovativo
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La sperimentazione clinica NCT07495956 è uno studio interventistico di Fase I Fase II volto a esaminare il trattamento per Diabete Mellito di Tipo II, attualmente in arruolamento. Avviato il 16 marzo 2026, prevede di arruolare 30 partecipanti. Sotto la guida di Shenzhen Geno-Immune Medical Institute, dovrebbe concludersi entro il 30 aprile 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus.
Descrizione dettagliata
Type II diabetes mellitus is a chronic metabolic disease with progressive islet β-cell dysfunction and insulin resistance as the core pathogenesis, leading to persistent hyperglycemia and a series of microvascular and macrovascular complications. Conventional treatments including lifestyle intervention, oral hypoglycemic agents and insulin injection can only control blood glucose levels, but cannot reverse the loss a...Mostra di più
Titolo ufficiale
Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
Patologie
Diabete Mellito di Tipo IIAltri ID dello studio
- GIMI-IRB-26002
Numero NCT
Data di inizio (effettiva)
2026-03-16
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2030-04-30
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Fase II
Stato
In arruolamento
Parole chiave
Clonal fetal MSCs (cfMSCs)
Islet function reconstruction
Insulin resistance
Type II diabetes mellitus
Islet function reconstruction
Insulin resistance
Type II diabetes mellitus
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleClonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus | cfMSC therapy for diabetes Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Number of patients with adverse events. | Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 24 weeks |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change of glycated hemoglobin (HbA1c) level. | Evaluate the improvement of long-term blood glucose control in patients, with the primary observation of the change range of HbA1c from baseline to 12 and 24 months after treatment. | 24 months |
Change of daily C-peptide level. | Detect the fasting and postprandial C-peptide levels to evaluate the recovery of endogenous insulin secretion function. | 24 months |
Change of daily exogenous insulin dosage. | Record the change of daily insulin dosage to evaluate the degree of insulin dependence reduction. | 24 months |
Proportion of patients achieving insulin independence. | Statistically analyze the number and proportion of patients who achieve complete or partial insulin independence after treatment and maintain the state for more than 6 months. | 36 months |
Incidence of diabetes-related complications. | Follow up and record the occurrence and progression of microvascular and macrovascular complications such as diabetic nephropathy, retinopathy and cardiovascular and cerebrovascular diseases. | 36 months |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Ability to understand the study protocol and voluntarily sign the written informed consent form;
- A clear diagnosis of type II diabetes mellitus for more than 3 years, with poor blood glucose control under conventional treatment (HbA1c ≥ 7.5% for 3 consecutive months);
- Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;
- Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;
- Karnofsky performance score (KPS) ≥ 70, with good daily living ability;
- Life expectancy > 5 years;
- Normal liver and kidney functions (bilirubin < 1.5×ULN, ALT/AST < 2.5×ULN, creatinine < 1.5×ULN); normal blood routine (absolute neutrophil count ≥ 1.8×10^9/L, platelets ≥ 100×10^9/L);
- No serious heart, brain, lung and other important organ diseases, and stable vital signs;
- Women of childbearing age have a negative pregnancy test within 7 days before enrollment, and all subjects of childbearing age agree to take effective contraceptive measures during the study and within 1 year after the end of the study; Willing to cooperate with the whole course of follow-up and complete all examination and observation indicators.
- Type 1 diabetes mellitus or other special types of diabetes;
- Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.;
- A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions;
- HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators;
- Active autoimmune diseases, or long-term use of glucocorticoids and immunosuppressants (except for small dose hormone replacement therapy);
- A history of severe allergic reactions, or allergy to the components of the study cell preparation;
- Pregnant or lactating women;
- Actively participating in other clinical research projects at the same time;
- Mental diseases or poor compliance that cannot cooperate with the study; Other conditions that the investigator deems unsuitable for participating in the study.
Shenzhen Geno-Immune Medical InstituteContatti principali dello studio
Contatto: Lung-Ji Chang, ph.D, +86 0755-86573763, [email protected]
1 Centri dello studio in 1 paesi
Guangdong
Shenzhen Geno-immune Medical Institute, Shenzhen, Guangdong, 518000, China
Lung-Ji Chang, ph.D, Contatto, +86 0755-86573763, [email protected]
In arruolamento