Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD) (NCT04995081) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)
United States60 participantsStarted 2021-07-16
Plain-language summary
This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease.
Who can participate
Age range
45 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female participants 45 - 80 years of age.
. At the screening visit, study participants must have an MDS-UPDRS part II score between 7 and 28.
. Study participants must have an MDS-UPDRS part III score between 20 and 57 during the screening visit.
. Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants.
. The total Levodopa equivalent dose for study participants must be less than 1400 mg per day.
. Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 2 years prior study participation.
. Study participants should be able to read, understand and to provide written consent.
. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed.
Exclusion criteria
. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures.
. Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used donor-derived stem cells from fat tissue — called allogeneic HB-adMSCs — rather than the patient's own cells. What are the risks of using someone else's cells, such as immune rejection or infection, and how do those risks compare to my current treatment options?
2The trial is now completed and was a Phase 2 study, which means it was still building evidence on safety and effectiveness. Have the results been published yet, and what did they show about whether patients with early or moderate Parkinson's actually improved on the motor and daily living scores they were measuring?
3The trial tracked motor symptoms and daily functioning using a scale called the MDS-UPDRS over 52 weeks. Based on what's been reported so far, how meaningful were the changes seen — and would a change that size actually matter to my quality of life day to day?
4Since this trial specifically enrolled people with early or moderate Parkinson's disease, would my current stage even fit the profile of who was studied, and is there a reason to consider this approach now versus waiting to see how my symptoms progress?
5Given that this trial is already completed, are there follow-on studies, expanded access programs, or similar stem cell trials I might be eligible for, or would you recommend sticking with established therapies like medication adjustments or deep brain stimulation first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in MDS-UPDRS Part III Total Score
Timeframe: Baseline to Weeks 52
2
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Timeframe: Baseline to Weeks 52
3
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Timeframe: Baseline to Weeks 52
4
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Timeframe: Baseline to Weeks 52
5
Change From Baseline in MDS-UPDRS Part II Total Score
Timeframe: Baseline to Weeks 52
6
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Timeframe: Baseline to Weeks 52
7
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
. Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
. Study participant has known alcoholic addiction or dependency or has current substance use or abuse.
. Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following:
. Study participant has received any stem cell treatment within 6 months before first dose of investigational product other than stem cells produced by Hope Biosciences.
. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
. Study participant has a laboratory abnormality during screening, including the following:
Timeframe: Baseline to Weeks 52
8
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week