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- Ensaio Clínico NCT07617012
The Safety, Tolerability, and Efficacy of Dopaminergic Neural Progenitor Cells (XS411CN Cell Injection) for the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P).
Phase I Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Stereotactic Intracerebral Transplantation of Human Allogeneic Induced Pluripotent Stem Cell-derived Dopaminergic Neural Progenitor Cells (XS411CN Cell Injection) for the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P).
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Michael LEE
- Número de telefone: +86 21 64027719
- E-mail: CEO@xellsmart.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female, aged 30 to 75;
- According to the 2022 International Movement Disorders Association's Diagnostic Criteria for Multiple System Atrophy, the patient meets the clinically confirmed and clinically probable diagnostic criteria for multiple system atrophy, and is diagnosed with Parkinson's type multiple system atrophy.
- MSA movement disorder symptoms have been present for no more than 5 years;
- The participant or their legal guardian must agree to the research protocol and sign a written informed consent form.
Exclusion Criteria:
- Patients diagnosed with primary Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, secondary Parkinsonian syndrome (cerebrovascular, drug-induced, traumatic, encephalitis), essential tremor, or other serious neurological diseases.
- Patients who have any impact or contraindications on any research procedure, including but not limited to: contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), contraindications to cranial MRI/PET examination, cranial CT/MRI showing severe brain atrophy, space-occupying lesions (such as brain tumors), hydrocephalus, cerebral vascular malformations, or structural abnormalities that researchers judge to affect transplantation or increase surgical risk.
- Patients diagnosed with primary Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, corticobasal degeneration, secondary Parkinsonian syndrome (cerebrovascular, drug-induced, traumatic, encephalitis), essential tremor, or other serious neurological diseases.
- Patients who have any impact or contraindications on any research procedure, including but not limited to: contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), contraindications to cranial MRI/PET examination, cranial CT/MRI showing severe brain atrophy, space-occupying lesions (such as brain tumors), hydrocephalus, cerebral vascular malformations, or structural abnormalities that researchers judge to affect transplantation or increase surgical risk.
- Patients with schizophrenia, severe depression (Hamilton Depression Rating Scale (HAMD-17) score ≥24), or severe anxiety (Hamilton Anxiety Rating Scale (HAMA) score ≥29);
- Patients with schizophrenia, severe depression (Hamilton Depression Rating Scale (HAMD-17) score ≥24), or severe anxiety (Hamilton Anxiety Rating Scale (HAMA) score ≥29);
- Patients who meet the diagnostic criteria for dementia (DSM-IV or ICD-10) ;
- Those who test positive for serious infectious diseases such as hepatitis A, active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody, or Treponema pallidum (TP) antibody;
- Any history of malignant tumors, excluding cured basal cell carcinoma and/or squamous cell carcinoma of the skin, cervical cancer in situ, or ductal carcinoma of the breast;
- Those with uncontrolled autoimmune diseases;
- Those who have been vaccinated or plan to be vaccinated during the trial within the three months prior to screening, such as with COVID-19, influenza, shingles, or pneumococcal vaccines;
- Women of childbearing age with a positive pregnancy test result before administration; women of childbearing age, unsterilized male participants whose partners are of childbearing age, and who have not used effective contraception for at least 6 months from the date of signing the ICF to the date of administration ; female participants who do not agree to never donate eggs and male participants who do not agree to never donate sperm from the date of signing the ICF to at least 6 months after administration.
- Patients who participated in other drug or medical device clinical trials within one month prior to receiving treatment;
- A history of long-term alcoholism or drug abuse;
- Any other situation that researchers deem unsuitable for participation in the research.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 9.0×10^6 cells/person/dose
9.0×10^6 cells/bilateral putamen.
|
Injection, 5.0×10^6 cells, once, 12 months
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To evaluate the safety and tolerability of stereotactic intracerebral transplantation of XS411CN cells for the treatment of MSA-P.
Prazo: Important safety events related to the investigational drug that occur within 28 days after administration.
|
Definition of important safety events: Any adverse event of grade 3 or higher that is related to the investigational drug (including definitely related, very likely related, and possibly related) and occurs within 28 days after administration of the investigational drug (graded according to the National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE) version 6.0). |
Important safety events related to the investigational drug that occur within 28 days after administration.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- XS411-Allo-MSA(-P)-CN1/2-P01
Plano para dados de participantes individuais (IPD)
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