Parkinson's DiseaseNCT01453803
Study to Assess the Safety and Effects of Autologous Adipose-Derived SVF Cells in Patients With Parkinson's Disease
A study testing Harvesting and Implantation of Adipose-Derived Stem Cells in people with Parkinson's Disease, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Harvesting and Implantation of Adipose-Derived Stem Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between Age 18 and 80 years.
- Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.
- Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.
- PD of Stage 2.5, 3 \& 4 of HOEHN \& YAHR staging.
- Stable Parkinsonian medications for the 60 days prior to the surgical therapy.
- MRI not showing gross atrophy or any other pathology of brain.
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- Patients with score less than 19 for the Montgomery-Asberg Rating Scale (MADRS) for Depression.
- NO Significant cognitive impairment.MMSE > 21.
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Who cannot join
- History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
- History of psychiatric disorders like schizophrenia or psychotic disorders.
- History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
- Contraindication for MRI
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
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- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgement, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Systolic blood pressure (supine) ≤90 mmHg;
- Resting heart rate > 100 bpm;
- Active clinical infection being treated by antibiotics within one week of enrollment.
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last two years.
- Unwilling and/or not able to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ageless Regenerative Institute LLC
Aventura, Florida, 33180
About this study
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously and Intranasally in Patients With Parkinson's Disease
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes.
Read the detailed description
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the Vertebral Artery and intravenously.
- Conditions
- Parkinson's Disease
- Being tested
- Harvesting and Implantation of Adipose-Derived Stem Cells
- Keywords
- Liposuction, ADSC, ASC, stem cell, Parkinson's Disease, Parkinson's, therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting and Implantation of Adipose-Derived Stem CellsProcedure or surgery
The adipose tissue specimen will be collected from the patient's abdomen or applicable region using a liposuction cannula. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for catheter injection.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Injection and Intanasal infusion of AD-SVF | Experimental | AD-SVF Receives: Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior
Improvement in Mentation, Behavior and mood in on and off position
Measured: 3 months
Number of participants with adverse events
Measured: 1 week
UPDRS- Improvement in Activities of Daily Living
Measured: 3 months
UPDRS- Improvement in motor Examination
Values compared to baseline
Measured: 3 months
UPDRS- MODIFIED HOEHN AND YAHR STAGING
Compared to baseline
Measured: 3 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
Measured: 3 months
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior
Improvement in Mentation, Behavior and mood in on and off position
Measured: 6 months
Number of participants with adverse events
Measured: 2 weeks
Number of participants with adverse events
Measured: 4 weeks
UPDRS- Improvement in Activities of Daily Living
Measured: 6 months
UPDRS- Improvement in motor Examination
Measured: 6 months
UPDRS- MODIFIED HOEHN AND YAHR STAGING
Measured: 6 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
Measured: 6 months
Secondary outcomes (4)
Reduction of Parkinson's medications
Measured: 3 months
Improvement in subjective symptoms: facial expression, gait, and freezing
Measured: 3 months
Reduction of Parkinson's medications
Measured: 6 months
Improvement in subjective symptoms: facial expression, gait, and freezing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startMay 2014
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: company dissolved
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453803
- Sponsor's protocol ID
- AD-US-PK-001
- Status last verified
- Nov 2017
- First submitted
- 3 Oct 2011
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously and Intranasally in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01453803
- Acronym / sponsor ID
- AD-US-PK-001
- Conditions
- Parkinson's Disease
- Keywords
- Liposuction, ADSC, ASC, stem cell, Parkinson's Disease, Parkinson's, therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company dissolved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Oct 2011 (estimated)
- 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.
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Parkinson's Disease and clinical outcomes.
Detailed description
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the Vertebral Artery and intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Injection and Intanasal infusion of AD-SVF | Experimental | Procedure: Harvesting and Implantation of Adipose-Derived Stem CellsAD-SVF |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and Females between Age 18 and 80 years.
- Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.
- Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.
- PD of Stage 2.5, 3 \& 4 of HOEHN \& YAHR staging.
- Stable Parkinsonian medications for the 60 days prior to the surgical therapy.
Key exclusion criteria (16 listed)
- History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
- History of psychiatric disorders like schizophrenia or psychotic disorders.
- History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
- Contraindication for MRI
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
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 |
|---|---|---|
| Harvesting and Implantation of Adipose-Derived Stem CellsThe adipose tissue specimen will be collected from the patient's abdomen or applicable region using a liposuction cannula. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for catheter injection. | Procedure or surgery | Intravenous Injection and Intanasal infusion of AD-SVF |
Primary outcome
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior
Time frame: 3 months
Improvement in Mentation, Behavior and mood in on and off position
Number of participants with adverse events
Time frame: 1 week
UPDRS- Improvement in Activities of Daily Living
Time frame: 3 months
UPDRS- Improvement in motor Examination
Time frame: 3 months
Values compared to baseline
UPDRS- MODIFIED HOEHN AND YAHR STAGING
Time frame: 3 months
Compared to baseline
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
Time frame: 3 months
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)Behavior
Time frame: 6 months
Improvement in Mentation, Behavior and mood in on and off position
Number of participants with adverse events
Time frame: 2 weeks
Number of participants with adverse events
Time frame: 4 weeks
UPDRS- Improvement in Activities of Daily Living
Time frame: 6 months
UPDRS- Improvement in motor Examination
Time frame: 6 months
UPDRS- MODIFIED HOEHN AND YAHR STAGING
Time frame: 6 months
UPDRS- SCHWAB AND ENGLAND ACTIVITIES OF DAILY LIVING SCALE
Time frame: 6 months
4 secondary outcomes
Reduction of Parkinson's medications
Time frame: 3 months
Improvement in subjective symptoms: facial expression, gait, and freezing
Time frame: 3 months
Reduction of Parkinson's medications
Time frame: 6 months
Improvement in subjective symptoms: facial expression, gait, and freezing
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvesting and Implantation of Adipose-Derived Stem Cells in people with Parkinson's Disease, run by Ageless Regenerative Institute at 1 site in United States.
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 9 inclusion and 16 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: withdrawn, as of the sponsor's last update on 24 Nov 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE)-Behavior (time frame: 3 months). The study lists 13 primary outcomes in all. 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 24 Nov 2017.