Stereotactic Transplantation of hAESCs for Parkinson's Disease

NCT04414813 | Completed Early Phase 1 DMC

• 1 other identifier: DFSC-2019（CR）-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of stereotactic transplantation of hAESCs for Parkinson's disease.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; stereotactic transplantation

Outcome Measures

Primary Outcomes (1)

• Number of Participants with adverse event and serious adverse event

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.

  12 months

Secondary Outcomes (8)

• Changes in Unified Parkinson's Disease Rating Scale (UPDRS) in ON and OFF state

  day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.

• Changes in the Hoehn and Yahr scale

  day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.

• Changes in Parkinson's Disease Questionnaire (PDQ-39)

  day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.

• Changes in the Schwab and England score

  day 0, 1 month, 2 month, 3 month, 6 month, 9 month and 12 month.

• Levodopa equivalent daily dose

  day 0, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month, 9 month and 12 month.

Study Arms (1)

hAESCs treatment

EXPERIMENTAL

50 millions hAESCs are transplanted to participants with PD.

Biological: Human Amniotic Epithelial Stem Cells

Interventions

Human Amniotic Epithelial Stem Cells BIOLOGICAL

Stereotactic transplantation of hAESCs for participants with PD.

hAESCs treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, with primary Parkinson's disease more than 5 years, male or female;
• The "off-stage"Hohen and Yahr grade of Parkinson's disease is from 2 to 4; and the"off-stage"UPDRS score is 38-70, difference between two scores before treatment is less than 10% ;
• The dosage of medicine is stable for more than 3 months;
• Levodopa treatment was effective ;
• Stable condition, good control of complications, no general anesthesia contraindications, no contraindications to stereotactic surgery and other conditions that interfere with clinical evaluation;
• No abnormalities affecting cell transplantation were found through head MRI;
• Patients shall be properly cared during treatment, and caregivers can provide assistance to the researcher if necessary.

You may not qualify if:

• Atypical Parkinson's disease, such as Parkinson's syndrome, secondary Parkinson's disease;
• Only having tremor syndrome;
• Serious movement disorders and cannot complete any routine exercise tasks;
• Symptoms of severe neurological deficits caused by other diseases;
• Severe mental symptoms or dementia;
• Patients are unwilling to cooperate or incapable of completing self-evaluation, and cannot complete the evaluator with the help of a doctor;
• History of striatum or extrapyramidal surgery, including deep brain stimulation (DBS);
• Ongoing treatment of apomorphine injecting ;
• Coagulation disorders or ongoing anticoagulation therapy;
• Women of childbearing age who do not take effective contraception;
• Pregnant or lactation;
• Patients who have participated in other clinical studies of drugs or medical devices within 3 months;
• Botox toxin, phenol, subarachnoid injection of baclofen or interventional therapy for the treatment of dystonia or spasticity within 6 months;
• History of seizures or taking prophylactic anti-epileptic drugs;
• General anesthesia or stereotactic surgery contraindications, such as sleep apnea, chronic obstructive pulmonary disease;

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China: collaborator

Study Sites (1)

WU Jingwen

Shanghai, Shanghai Municipality, 200000, China

Location

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 Officials

• WU Jingwen, Dr

  Shanghai East Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study plans to recruit 3 patients who meet the criteria. 50 millions HAESCs will be transplanted to participants with PD.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 4, 2020
• Study Start: October 8, 2020
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)