Parkinson DiseaseNCT06056427
Intermediate Size Expanded Access Protocol Using Autologous HB-adMSCs for the Treatment of Parkinson's Disease
A study testing HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells) in people with Parkinson Disease, run by Hope Biosciences Research Foundation.
Trial summary
This expanded access protocol is part of IND 027396 to evaluate efficacy and safety of multiple intravenous administrations of autologous HB-adMSCs for the treatment of Parkinson's disease for up to 11 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Patients must have passed pre-screening for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Patients must have screened for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Patients must have not been randomized into the treatment group for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Male and female participants 18 - 80 years of age.
- Patients must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before participation.
- Patients must have previously banked their mesenchymal stem cells with Hope Biosciences.
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- Patients should be able to read, understand and to provide written consent.
- Voluntarily signed informed consent obtained before any expanded access-related procedures are performed.
- Female patients should not be pregnant or plan to become pregnant during participation and for 6 months after last investigational product administration.
- Male patients if their sexual partners can become pregnant should use a method of contraception during participation and for 6 months after the last administration of the investigated product.
- Patient is able and willing to comply with the requirements of this Expanded Access.
Who cannot join
- Patients with advanced Parkinson's disease. Advanced PD is defined as a significant disability, wheelchair-bound or bedridden.
- Any malignancy or clinical evidence that supports the presence of a malignant process in a patient is being investigated. Malignancy is defined as any form of cancer that had occurred in the previous five years before the first infusion and may require surgery, chemotherapy, or radiation.
- Patients with medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 150/90 mm/Hg during screening visit.
- Patients with the following concomitant or past medical history:
- Heart Failure - New York Heart Association (NYHA) Class III/IV.
- Heart Attack (in the past six months before 1st infusion).
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- Stroke (in the past six months before 1st infusion).
- Hepatitis B or C.
- Human immunodeficiency virus (HIV) infection.
- Any of the following abnormal lab findings during screening will disqualify a patient from this expanded access protocol:
- Hemoglobin (Hgb) <10 G/DL or >18 G/DL
- Hematocrit (HCT) <30% or >55%
- Platelet count < 80 K/UL and or > 450 K/UL.
- White blood cell count WBC < 3.0 K/UL and > 13.0 K/UL.
- Alanine aminotransferase (ALT) of > 75 IU/L
- Aspartate aminotransferase (AST) of > 75 IU/L
- eGFR < 40 mL/min/1.73
- Pre-prandial glucose > 150 MG/DL
- Post-prandial glucose > 200 MG/DL
- Patients who have received any stem cell treatment in the past six months before 1st infusion other than stem cells produced by Hope Biosciences.
- Patients who are unlikely to complete the visits or adhere to the procedures.
- The patient has previously been diagnosed with a psychiatric disorder, which is currently uncontrolled.
- Patients with a history of addiction or dependency or currently abusing or using substances.
- Patients with any form of kidney dialysis will be excluded from participation in the investigation.
- Patients who have received an experimental drug in the past 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations).
- Patients who the Investigator determines to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.
- Patients who have recently undergone major surgery (in the past six months before 1st infusion). Some examples of major surgeries include, but are not limited to, the following: heart surgeries, aortic aneurysm bypass, organ transplant, intracranial surgery, spinal laminectomy or fusion, amputation, resection of the lung, resection of esophagus, resection of a mediastinal mass, resection of bladder or prostate tumor and resection of kidney or ureter.
About this study
Official title: An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Autologous HB-adMSCs for the Treatment of Patients With Parkinson's Disease
This expanded access protocol is part of IND 027396 to evaluate efficacy and safety of multiple intravenous administrations of autologous HB-adMSCs for the treatment of Parkinson's disease for up to 11 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBPD03 clinical study protocol entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Conditions
- Parkinson Disease
- Being tested
- HB- adMSCs (Hope Biosciences adipose derived 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.
HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)Biological
Participants will receive autologous HB-adMSCs through intravenous infusion only, with a treatment duration of 18 weeks, infusion rate 4-5mL/min and total volume of 250 mL Sodium chloride 0.9%. Each participant will receive a total of 6 doses of HB-adMSCs with a dosing regimen of approximately 2 weeks between infusion 1 and infusion 2, and 4 weeks between the remaining infusions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Djamchid Lotfi, MD, Principal investigator, Hope Biosciences Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056427
- Sponsor's protocol ID
- HBPD06
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Autologous HB-adMSCs for the Treatment of Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06056427
- Acronym / sponsor ID
- HBPD06
- Conditions
- Parkinson Disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- First posted
- 28 Sep 2023 (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 expanded access protocol is part of IND 027396 to evaluate efficacy and safety of multiple intravenous administrations of autologous HB-adMSCs for the treatment of Parkinson's disease for up to 11 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBPD03 clinical study protocol entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have passed pre-screening for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Patients must have screened for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Patients must have not been randomized into the treatment group for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
- Male and female participants 18 - 80 years of age.
- Patients must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before participation.
Key exclusion criteria (27 listed)
- Patients with advanced Parkinson's disease. Advanced PD is defined as a significant disability, wheelchair-bound or bedridden.
- Any malignancy or clinical evidence that supports the presence of a malignant process in a patient is being investigated. Malignancy is defined as any form of cancer that had occurred in the previous five years before the first infusion and may require surgery, chemotherapy, or radiation.
- Patients with medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 150/90 mm/Hg during screening visit.
- Patients with the following concomitant or past medical history:
- Any of the following abnormal lab findings during screening will disqualify a patient from this expanded access protocol:
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 |
|---|---|---|
| HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)Participants will receive autologous HB-adMSCs through intravenous infusion only, with a treatment duration of 18 weeks, infusion rate 4-5mL/min and total volume of 250 mL Sodium chloride 0.9%. Each participant will receive a total of 6 doses of HB-adMSCs with a dosing regimen of approximately 2 weeks between infusion 1 and infusion 2, and 4 weeks between the remaining infusions. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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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.
Djamchid Lotfi, MD principal investigator
Hope Biosciences Research Foundation
Questions about this trial
What is this clinical trial studying?
A study testing HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells) in people with Parkinson Disease, run by Hope Biosciences Research Foundation.
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 11 inclusion and 27 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 29 Sep 2025. 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.
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.
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 29 Sep 2025.