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O estudo clínico NCT07495956 para Diabetes Mellitus Tipo II está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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cfMSC Therapy for Diabetes Fase I, Fase II 30 Inovador
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O estudo clínico NCT07495956 procura avaliar tratamento para Diabetes Mellitus Tipo II. Este é um estudo intervencionista de Fase I Fase II. Seu status atual é: em recrutamento. O estudo começou em 16 de março de 2026 e pretende incluir 30 participantes. Coordenado por Shenzhen Geno-Immune Medical Institute e deve ser concluído em 30 de abril de 2030. Essas informações foram atualizadas no ClinicalTrials.gov em 27 de março de 2026.
Resumo
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.
Descrição detalhada
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...Mostrar mais
Título oficial
Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
Condições médicas
Diabetes Mellitus Tipo IIOutros IDs do estudo
- GIMI-IRB-26002
Número NCT
Data de início (real)
2026-03-16
Última atualização postada
2026-03-27
Data de conclusão (estimada)
2030-04-30
Inscrição (estimada)
30
Tipo de estudo
Intervencionista
FASE
Fase I
Fase II
Fase II
Status
Em recrutamento
Palavras-chave
Clonal fetal MSCs (cfMSCs)
Islet function reconstruction
Insulin resistance
Type II diabetes mellitus
Islet function reconstruction
Insulin resistance
Type II diabetes mellitus
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalClonal 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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 InstituteContato central do estudo
Contato: Lung-Ji Chang, ph.D, +86 0755-86573763, [email protected]
1 Locais do estudo em 1 países
Guangdong
Shenzhen Geno-immune Medical Institute, Shenzhen, Guangdong, 518000, China
Lung-Ji Chang, ph.D, Contato, +86 0755-86573763, [email protected]
Em recrutamento