Parkinson's DiseasePhase 1NCT03550183
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's Disease
A Phase 1 study testing mesenchymal stem cells in people with Parkinson's Disease, run by Hebei Newtherapy BIo-Pharma technology Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2018to 30 Dec 2022
- Phase
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 40 to 60 years, and no limitation of gender.
- Diagnosis of primary Parkinson's disease(PD) according to Movement Disorder Society (MDS)-PD criteria established in 2015.
- Hoehn-Yahr Stages from I to IV stage.
- Drugs for anti Parkinson's disease have been taken over 28 days before entering the group.
- MMSE score≥25
- No antidepressant or antipsychotic drugs were received within 2 weeks.
- Understanding and willingness to sign a written informed consent document.
Who cannot join
- Patients with PD have to be disqualified from this study if any of the following is applicable.
- Patients with psychiatric history, but depression.
- Suicidal tendency or behavior of patients.
- Patients with severe cognitive impairment, chronic organ failure or malignant tumor.
- The value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was 1.5 times higher than that of the normal reference; or leucocyte count<1000/μl.
- Pregnancy and lactating women.
- The patient is taking part in other drug tests, or received other research medication within 90 days before entering the group.
- Patients who had quit our study could not enter it again.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Newtherapy BIo-Pharma Technology Co., Ltd
Shijiazhuang, Hebei, 050000
About this study
Official title: Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative movement disorder，which mainly shows up in the elderly. And there is as yet no effective drug treatment. Umbilical cord derived mesenchymal stem cells (UC-MSCs) derived from mesoderm owns strong proliferation ability and multiple differentiation potential. The investigators used UC-MSCs via intravenous infusion to treat PD. With different durations of follow-up, the investigators cleared therapeutic effect, the quality of life and prognostic implications of UC-MSCs on PD through the Unified Parkinson's Disease Rating Scale (UPDRS), revised Hoehn-Yahr（H-Y） staging, Mini-Mental State Examination (MMSE), Hamilton depression scales 24 (HAMD 24), Hamilton Anxiety Scale 14 (HAMA 14) and Clinical Global Impression (CGI). In this research, the investigators seek new therapeutic approaches for PD, and provide clinical evidences for the clinical application of UC-MSCs in the future.
- Conditions
- Parkinson's Disease
- Being tested
- mesenchymal stem 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.
mesenchymal stem cellsBiological
Patients with PD in the therapy group were given UC-MSCs by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1 month, 3 months, 6 months and 12 months were evaluated respectively the curative effect.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Selected patients with Parkinson's disease were randomly divided into a therapy group and a control group. Umbilical Cord Derived Mesenchymal Stem Cells(UC-MSCs) at a dose of 10-20 million by intravenous infusion.Patients in the therapy group treated once a week with UC-MSCs. Each course of treatment Lasted 3 weeks. Receives: Biological: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS was assessed to identify the severity of PD. It includes the four-scale structure with a reorganization of the various subscales. This four-scale structure are (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Measured: Post cell transplantation: 1, 3, 6, 12months
Secondary outcomes (5)
Changes of in the Hoehn and Yahr staging
Hoehn and Yahr (H-Y) staging was used to determine the stage of PD based on clinical findings and functional disability. In H-Y staging is a rating scale measured in an ordinal level.
Measured: Post cell transplantation: 1, 3, 6, 12months
Changes of the Mini-Mental State Examination (MMSE)
The MMSE was used to measure cognition. This test consists of 2 parts: language and performance. Its total score can range from 0 to 30, with a higher score indicating better function.
Measured: Post cell transplantation: 1, 3, 6, 12months
Changes of the Hamilton depression scales 24 (HAMD 24)
The HAMD 24 is used to assessed the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. There are 24 items in the HAMD 24.
Measured: Post cell transplantation: 1, 3, 6, 12months
Changes of the Hamilton Anxiety Scale 14 (HAMA-14)
The HAMA-14 is used to assessed the anxiety symptoms. Its total score can range from 0 to 56. Lower score represents a better outcome.
Measured: Post cell transplantation: 1, 3, 6, 12months
Adverse reaction
Adverse reaction including temperature changes,the change of blood pressure,allergy and so on.
Measured: Post cell transplantation: 1, 3, 6, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start10 Jan 2018
- Primary completion10 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Newtherapy BIo-Pharma technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Shengjun An, Hebei Newtherapy BIo-Pharma technology Co., Ltd.
- Investigators
- Xiqing Chai, Doctor, Study chair, Hebei Chemical & Pharmaceutical CollegePing Gu, Doctor, Study director, The First Hospital of Hebei Medical UniversityHongxu Chen, Master, Study director, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550183
- Sponsor's protocol ID
- 18967728D
- Status last verified
- Dec 2021
- First submitted
- 11 May 2018
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT03550183
- Acronym / sponsor ID
- 18967728D
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Newtherapy BIo-Pharma technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Jun 2018 (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 study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in Parkinson's disease.
Detailed description
Parkinson's disease (PD) is a neurodegenerative movement disorder，which mainly shows up in the elderly. And there is as yet no effective drug treatment. Umbilical cord derived mesenchymal stem cells (UC-MSCs) derived from mesoderm owns strong proliferation ability and multiple differentiation potential. The investigators used UC-MSCs via intravenous infusion to treat PD. With different durations of follow-up, the investigators cleared therapeutic effect, the quality of life and prognostic implications of UC-MSCs on PD through the Unified Parkinson's Disease Rating Scale (UPDRS), revised Hoehn-Yahr（H-Y） staging, Mini-Mental State Examination (MMSE), Hamilton depression scales 24 (HAMD 24), Hamilton Anxiety Scale 14 (HAMA 14) and Clinical Global Impression (CGI). In this research, the investigators seek new therapeutic approaches for PD, and provide clinical evidences for the clinical application of UC-MSCs in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cellsSelected patients with Parkinson's disease were randomly divided into a therapy group and a control group. Umbilical Cord Derived Mesenchymal Stem Cells(UC-MSCs) at a dose of 10-20 million by intravenous infusion.Patients in the therapy group treated once a week with UC-MSCs. Each course of treatment Lasted 3 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 40 to 60 years, and no limitation of gender.
- Diagnosis of primary Parkinson's disease(PD) according to Movement Disorder Society (MDS)-PD criteria established in 2015.
- Hoehn-Yahr Stages from I to IV stage.
- Drugs for anti Parkinson's disease have been taken over 28 days before entering the group.
- MMSE score≥25
Key exclusion criteria (8 listed)
- Patients with PD have to be disqualified from this study if any of the following is applicable.
- Patients with psychiatric history, but depression.
- Suicidal tendency or behavior of patients.
- Patients with severe cognitive impairment, chronic organ failure or malignant tumor.
- The value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was 1.5 times higher than that of the normal reference; or leucocyte count<1000/μl.
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 |
|---|---|---|
| mesenchymal stem cellsPatients with PD in the therapy group were given UC-MSCs by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1 month, 3 months, 6 months and 12 months were evaluated respectively the curative effect. | Biological | mesenchymal stem cells |
Primary outcome
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Post cell transplantation: 1, 3, 6, 12months
The UPDRS was assessed to identify the severity of PD. It includes the four-scale structure with a reorganization of the various subscales. This four-scale structure are (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
5 secondary outcomes
Changes of in the Hoehn and Yahr staging
Time frame: Post cell transplantation: 1, 3, 6, 12months
Changes of the Mini-Mental State Examination (MMSE)
Time frame: Post cell transplantation: 1, 3, 6, 12months
Changes of the Hamilton depression scales 24 (HAMD 24)
Time frame: Post cell transplantation: 1, 3, 6, 12months
Changes of the Hamilton Anxiety Scale 14 (HAMA-14)
Time frame: Post cell transplantation: 1, 3, 6, 12months
Adverse reaction
Time frame: Post cell transplantation: 1, 3, 6, 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
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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.
Xiqing Chai, Doctor study chair
Hebei Chemical & Pharmaceutical College
Ping Gu, Doctor study director
The First Hospital of Hebei Medical University
Hongxu Chen, Master study director
The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mesenchymal stem cells in people with Parkinson's Disease, run by Hebei Newtherapy BIo-Pharma technology Co., Ltd. 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 7 inclusion and 8 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 30 Dec 2021. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes of the Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: Post cell transplantation: 1, 3, 6, 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2021.