A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient

NCT ID: NCT03128450

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2018-11-01

Brief Summary

This Pilot study will evaluate the safety and Efficacy of an investigational cell transplantation therapy, h-NSC, in patients with Parkinson's disease, through nasal drug delivery, a new delivery way. All patients will receive the therapy, which consists of human neural stem cells,

Detailed Description

h-NSC is a cellular therapeutic consisting of human fetal neural stem cells (h-NSC). h-NSC injection will be delivered through nasal way for patients with Parkinson's disease (PD).

The study will enroll 12 moderate to severe PD patients to be treated with the cell injection therapy at the same dose. The total therapy course will be four weeks，one dose for one week. The follow up will be two times within 24 weeks after finishing the treatment. The main objective of the study is to evaluate the efficacy and safety of the cell transplantation by this new delivery way.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

h-NSC arm

human neural stem cell: 100ul/vessel，2 vessel/one bag，≥2×10 6cells/vessel，produced by Shanghai Angecon Biotechology Cooperate.

One enrolled PD patient was given 2 vessels h-NSC througth nasal cavity weekly for 4 weeks。Total cell number will be over ≥4×10 6cells for one time.

Group Type: EXPERIMENTAL

human neural stem cell

Intervention Type: BIOLOGICAL

human neural stem cell: 100ul/vessel，2 vessel/one bag，≥2×10 6cells/vessel

Interventions

human neural stem cell

human neural stem cell: 100ul/vessel，2 vessel/one bag，≥2×10 6cells/vessel

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patient diagnosed with idiopathic PD, at least with two key symptoms (Static tremor, bradykinesia, rigidity ) , without any other evidence of Secondary Parkinson's syndrome.
• Disease course ≥7 years，modified Hoehn-Yahr is 3-5 stage
• Patient age ≥35 years
• Patients receiving a stable dose of levodopa for at least 1 months with the expectation that the treatment will remain unchanged throughout the course of the study
• The doses of levodopa ≥300mg •Signed informed consent form (ICF) by patient self or his law-in relationship before enrollment.

Exclusion Criteria

• Hepatic dysfunction(transaminase ≥1.5 normal range), Renal dysfunction(Cr>2.0mg/dl or 177μmol/L)，Cardiac dysfunction or other severe systematic diseases etc.
• Suffering malignancy or during anti-cancer treatment period.
• Pregancy, lactation or possible pregancy and plan to pregancy patient
• Attended other intervention clinical trial within 3 months aftre getting ICF, or during other ongoing intervention clinical trial
• Investigator think inappropriate patient for this protocol

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Chun-Feng Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jie Li

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou

Locations

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

References

Hallett PJ, Cooper O, Sadi D, Robertson H, Mendez I, Isacson O. Long-term health of dopaminergic neuron transplants in Parkinson's disease patients. Cell Rep. 2014 Jun 26;7(6):1755-61. doi: 10.1016/j.celrep.2014.05.027. Epub 2014 Jun 6.

Reference Type: RESULT

PMID: 24910427 (View on PubMed)

Kefalopoulou Z, Politis M, Piccini P, Mencacci N, Bhatia K, Jahanshahi M, Widner H, Rehncrona S, Brundin P, Bjorklund A, Lindvall O, Limousin P, Quinn N, Foltynie T. Long-term clinical outcome of fetal cell transplantation for Parkinson disease: two case reports. JAMA Neurol. 2014 Jan;71(1):83-7. doi: 10.1001/jamaneurol.2013.4749.

Reference Type: RESULT

PMID: 24217017 (View on PubMed)

Other Identifiers

Second Affiliated Hospital

Identifier Type: -

Identifier Source: org_study_id