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

Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease

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

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Ips-nsc cells

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;
2. The subject is clearly diagnosed with Parkinson's;
3. Recorded disease progression over the past 6 months;
4. 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;
5. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• 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: ips-nsc treatment group	Drug: Ips-nsc cells; Total dose of ips-nsc cells will be administered at day0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of treatment related adverse events	occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NSC-PD-YNYY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No