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Parkinson DiseasePhase 2/3hNSCPDNCT03128450

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

A Phase 2/3 study testing human neural stem cell in people with Parkinson Disease, run by Second Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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, Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Parkinson Disease
What is being tested?
human neural stem cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
15 Apr 2017to 1 Nov 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Neurology, Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

Other trials in China

About this study

Official title: A Single Arm, Open-Label，Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease

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,

Read the 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.

Being tested
human neural stem cell
Keywords
Parkinson Disease, Neural stem cell, Nasal delivery
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human neural stem cellBiological

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

Study groups in NCT03128450
Study groupRoleWhat they receive
h-NSC armExperimentalhuman 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.
Receives: Biological: human neural stem cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of Unified Parkinson's Disease Reting Scale(UPDRS)score from baseline

    Improvement rate of UPDRS motor score defined as below:

    Reduction rate =（baseline score 16, 28 weeks score after therapy）/ baseline score×100%.

    Based on reduction rate, the efficacy can be defined as complete remission, partial remission, effective and invalid The reduction rate will be 100%, >50%, >25-50%, ≤ 25% for complete remission, partial remission, effective and invalid.

    The improvement rate =[(complete+partial+effective patient number)/total patient number]×100％

    Measured: Baseline and 16, 28 weeks

Secondary outcomes (13)

  1. motor function index

    Hoehn-Yahr modified score

    Measured: baseline and 16, 28 weeks

  2. Non-motor function score:cognitive function

    Minimum Mental State Examination and Montreal Cognitive Assessment to assess cognitive function

    Measured: baseline and 16, 28 weeks

  3. Non-motor function score:smell

    Argentina Hyposmia Rating Scales is used to detect the smell

    Measured: baseline and 16, 28 weeks

  4. Non-motor function score:fatigue

    Fatigue Severity Scale to assess the extent of fatigue

    Measured: baseline and 16, 28 weeks

  5. Non-motor function score:emotion

    Hamilton Depression Scale to evaluate the degree of depression, Hamilton Anxiety Scale to evaluate the degree of anxiety

    Measured: baseline and 16, 28 weeks

  6. Non-motor function score:non-motor symptoms

    non-motor symptoms in PD patients is evaluated used Non-motor Symptoms Questionnaire

    Measured: baseline and 16, 28 weeks

  7. Non-motor function score:autonomic symptoms

    The scale for outcomes in PD for autonomic symptoms to assess autonomic dysfunction

    Measured: baseline and 16, 28 weeks

  8. Non-motor function score:the quality of life.

    The 39-item Parkinson's disease questionnaire to assess the quality of life.

    Measured: baseline and 16, 28 weeks

  9. Immunological index

    CD3(%)，CD4(%)，CD8(%)，Treg cells(%)

    Measured: baseline and 16, 28 weeks

  10. Imaging index

    Magnetic Resonance Imaging or positron emission tomography

    Measured: baseline and 16, 28 weeks

  11. Blood routine examination

    Blood routine examination includes the total number of red blood cells, hemoglobin, total number of white blood cells, white blood cells count, platelet count.

    Measured: baseline and 16, 28 weeks

  12. Biochemical routine examination

    Biochemical routine examination includes liver function, renal function, blood glucose, blood lipid

    Measured: baseline and 16, 28 weeks

  13. Safety index

    Adverse Event and Serious Adverse Event

    Measured: 1,2,3,4,weeks and 16, 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start15 Apr 2017
  3. Primary completion1 Jun 2018 (estimated)
  4. Study completion1 Nov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03128450
Sponsor's protocol ID
Second Affiliated Hospital
Acronym
hNSCPD
Status last verified
May 2017
First submitted
9 Feb 2017
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will decisde if the IPD based on patient consent

Publications

  • 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.

    PubMed 24910427

  • 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.

    PubMed 24217017

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing human neural stem cell in people with Parkinson Disease, run by Second Affiliated Hospital of Soochow University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of Unified Parkinson's Disease Reting Scale(UPDRS)score from baseline (time frame: Baseline and 16, 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03128450, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.

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