A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells

NCT03815071 | Unknown Early Phase 1

• 1 other identifier: NSC-PD-YNYY-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• occurrence of treatment related adverse events

  occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.

  1 year

Study Arms (1)

ips-nsc treatment group

EXPERIMENTAL

Drug: Ips-nsc cells

Interventions

Ips-nsc cells DRUG

Total dose of ips-nsc cells will be administered at day0.

ips-nsc treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;
• The subject is clearly diagnosed with Parkinson's;
• Recorded disease progression over the past 6 months;
• Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg/dl;
• Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;

You may not qualify if:

• Mental illness or a neurological disease not associated with Parkinson's disease;
• Serious other concomitant diseases (tumor, organ failure, etc.);
• Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;
• Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;
• There are already cognitive impairments or depressions, etc., and the research cannot be completed well;
• Female subjects who are breast-feeding or have a pregnancy plan recently.

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead
• The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Beijing Hospital: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 24, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share