Parkinson DiseaseEarly Phase 1NCT03815071

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

A Early Phase 1 study testing Ips-nsc cells in people with Parkinson Disease, run by Allife Medical Science and Technology Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Parkinson Disease
What is being tested?: Ips-nsc cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: 1 Feb 2019to 1 Feb 2021
Phase: Early Phase 1
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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

Conditions: Parkinson Disease
Being tested: Ips-nsc cells
Medical subject headings: Parkinson Disease

What participants receive

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

Ips-nsc cellsDrug
Total dose of ips-nsc cells will be administered at day0.

Study groups in NCT03815071
Study group	Role	What they receive
ips-nsc treatment group	Experimental	Not described Receives: Drug: Ips-nsc cells

What is being measured

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

occurrence of treatment related adverse events
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
Measured: 1 year

Timeline

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

1 Feb 20191 Feb 2021

First posted24 Jan 2019
Study start1 Feb 2019 (estimated)
Primary completion1 Feb 2020 (estimated)
Study completion1 Feb 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03815071
Sponsor's protocol ID: NSC-PD-YNYY-01
Status last verified: Jan 2019
First submitted: 21 Jan 2019
Last updated: 31 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
ClinicalTrials.gov ID: NCT03815071
Acronym / sponsor ID: NSC-PD-YNYY-01
Conditions: Parkinson Disease
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Allife Medical Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: The First People's Hospital of Yunnan, Henan Provincial People's Hospital, Beijing Hospital
Study start: 1 Feb 2019 (estimated)
Primary completion: 1 Feb 2020 (estimated)
Study completion: 1 Feb 2021 (estimated)
First posted: 24 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ips-nsc treatment group	Experimental	Drug: Ips-nsc cells

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

Mental illness or a neurological disease not associated with Parkinson's disease;
Serious other concomitant diseases (tumor, organ failure, etc.);
Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;
Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;
There are already cognitive impairments or depressions, etc., and the research cannot be completed well;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ips-nsc cellsTotal dose of ips-nsc cells will be administered at day0.	Drug	ips-nsc treatment group

Primary outcome

occurrence of treatment related adverse events
Time frame: 1 year
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
Individual participant dataSharing planned: No

Related trials for Parkinson Disease

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ips-nsc cells in people with Parkinson Disease, run by Allife Medical Science and Technology Co., Ltd..

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 6 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

occurrence of treatment related adverse events (time frame: 1 year). 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 NCT03815071.

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 31 Jan 2019.