The Safety, Tolerability, and Efficacy of Dopaminergic Neural Progenitor Cells (XS411CN Cell Injection) for the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P).

XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

Status and phase

Not yet enrolling

Phase 1

Conditions

the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P)

Treatments

Drug: XS411CN Cell Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07617012

XS411-Allo-MSA(-P)-CN1/2-P01

Details and patient eligibility

About

A Phase I Study to Assess the Safety, Tolerability and Efficacy of dopaminergic neural progenitor cells (XS411CN cell injection) for the treatment of multiple system atrophy Parkinsonian variant (MSA-P).

Enrollment

3 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.