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Not yet recruitingNCT07617012Updated Jun 1, 2026

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

A Phase 1 interventional study of XS411CN Cell Injection in the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P), sponsored by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.. Not yet recruiting. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
30 Years to 75 Years
Sex
All
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Study summary

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).

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Conditions studied

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

Lead sponsor

XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (estimated)

Study arms

  • Experimental
    9.0×10^6 cells/person/dose

    9.0×10\^6 cells/bilateral putamen.

    Drug: XS411CN Cell Injection

Interventions

  • DrugXS411CN Cell Injection

    Injection, 5.0×10\^6 cells, once, 12 months

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Important safety events related to the investigational drug that occur within 28 days after administration.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07617012
Lead sponsor
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Jun 1, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Aug 30, 2026 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jun 1, 2026

Study contacts

Michael LEE
Contact
CEO@xellsmart.com
+86 21 64027719

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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