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).

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).

Study Overview

• Status: Not yet recruiting
• Conditions: the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P)
• Intervention / Treatment: Drug: XS411CN Cell Injection

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Michael LEE; Phone Number: +86 21 64027719; Email: CEO@xellsmart.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9.0×10^6 cells/person/dose; 9.0×10^6 cells/bilateral putamen.	Drug: XS411CN Cell Injection; Injection, 5.0×10^6 cells, once, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of stereotactic intracerebral transplantation of XS411CN cells for the treatment of MSA-P.	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.

Collaborators and Investigators

• Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: XS411-Allo-MSA(-P)-CN1/2-P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No