NCT01860794

Brief Summary

The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

8.9 years

First QC Date

May 14, 2013

Last Update Submit

July 9, 2020

Conditions

Idiopathic Parkinson DiseasePrimary Parkinsonism

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of cancer foramtion and infection

    If not included in the following criteria, the cells are are considered to be safe and tolerable. * Cells with grade 3 or more in NCI grading system * Cells contaminated with infectious materials * Cells with risk of cancer formation

    5 years

Secondary Outcomes (11)

  • Score of Unified Parkinson's Disease Rating Scale (UPDRS)

    5 years

  • Detection of positron emission in Putamen using Positron emission tomograph(PET)

    5 years

  • Dyskinesia scale scores(CAPSIT-PD)

    5 years

  • Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test

    5 years

  • Score of activity of daily living (ADL) scale

    5 years

  • +6 more secondary outcomes

Study Arms (1)

Mesencephalic Neuronal Precursor Cells

OTHER
Drug: Mesencephalic Neuronal Precursor Cells

Interventions

Mesencephalic Neuronal Precursor CellsDRUG

All the patients are continuously registered for this study. Data monitoring committee inspects the clinical results of first patient and decides whether the treatment for four subjects are appropriate to proceed. 5 subjects of each group are subject to inspection by Data monitoring committee after the end of tracking fifth patients.

Mesencephalic Neuronal Precursor Cells

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with idiopathic or primary Parkinson's disease
  • Hoehn and Yare (HY) stage III or IV
  • more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning
  • Patients aged less than 70
  • Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery

You may not qualify if:

  • Atypical or secondary parkinsonism
  • Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30
  • Psychological disorders (illusion, delusion, schizophrenia)
  • Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24
  • Epilepsy
  • Medial history of brain surgery
  • Medical history of other brain diseases
  • Hemorrhagic tendency
  • Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer
  • Experience of participating in clinical trial within 30 days
  • Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls
  • Pregnant or lactating women
  • Patients who are not considered to be eligible to participate in clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sang Sup Chung, M.D., Ph.D.

    CHA University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Sup Chung, M.D., Ph.D.

CONTACT

82-31-780-5261jmoon@cha.ac.kr

Joo pyung Kim, M.D., Ph.D.

CONTACT

82-31-780-5000jpkim@cha.ac.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 23, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

KR(1)