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Stem Cell Therapy
Stem Cell Therapy for Parkinson's Disease (HBPD04 Trial)
Phase 2
Recruiting
Led By Djamchid Lotfi, MD
Research Sponsored by Hope Biosciences Stem Cell Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The total Levodopa equivalent dose for study participants must be less than 1400 mg per day
Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 8, 16, 24, 32, 42 and 52.
Awards & highlights
HBPD04 Trial Summary
This trial is a phase 2 study testing the efficacy and safety of allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease. Up to 60 participants will be enrolled, with a screening period of up to 4 weeks, a 32- week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration.
Who is the study for?
This trial is for men and women aged 45-80 with early to moderate Parkinson's disease diagnosed at least 2 years ago. Participants must not have severe disability, active cancer, major psychiatric conditions, or recent stem cell treatments. They should be on a stable dose of Parkinson's medication and willing to use contraception if necessary.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of allogeneic HB-adMSCs (a type of stem cell therapy) compared to a placebo in treating Parkinson's disease. It is randomized and double-blind, meaning neither the researchers nor participants know who receives the real treatment versus placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at injection sites, immune responses against the cells, or other unforeseen complications related to stem cell therapies.
HBPD04 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I take less than 1400 mg of Levodopa or its equivalent daily.
Select...
I take less than 1200 mg of Carbidopa/Levodopa daily.
Select...
I am between 45 and 80 years old.
HBPD04 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 4, 8, 16, 24, 32, 42 and 52.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 8, 16, 24, 32, 42 and 52.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1. Changes in the total score MDS-UPDRS Part II.
10. Laboratory values Coagulation Panel; Prothrombin time, Partial Prothrombin time, and INtern
Respiratory rate
+14 moreSecondary outcome measures
18. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part I.
19. Changes in the total score Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part II and Part III.
20. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III.
+7 moreHBPD04 Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Allogeneic HB-adMSCs.Active Control2 Interventions
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
Group II: PlaceboPlacebo Group2 Interventions
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mesenchymal stem cells (MSCs), including those derived from bone marrow or adipose tissue, are being studied for their potential to repair or replace damaged cells and modulate the immune response in Parkinson's Disease (PD). This is significant for PD patients because the disease involves the degeneration of dopaminergic neurons in the brain.
MSCs could promote the survival of these neurons and reduce inflammation, offering a novel therapeutic approach that addresses the underlying neurodegeneration, unlike traditional treatments that primarily manage symptoms through dopamine replacement or modulation.
[Cell therapy for Parkinson's disease with induced pluripotent stem cells].Intravenous mesenchymal stem cell administration exhibits therapeutic effects against 6-hydroxydopamine-induced dopaminergic neurodegeneration and glial activation in rats.
[Cell therapy for Parkinson's disease with induced pluripotent stem cells].Intravenous mesenchymal stem cell administration exhibits therapeutic effects against 6-hydroxydopamine-induced dopaminergic neurodegeneration and glial activation in rats.
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Who is running the clinical trial?
Hope Biosciences Stem Cell Research FoundationLead Sponsor
21 Previous Clinical Trials
280 Total Patients Enrolled
Hope BiosciencesIndustry Sponsor
23 Previous Clinical Trials
266 Total Patients Enrolled
Djamchid Lotfi, MDPrincipal InvestigatorHope Biosciences Stem Cell Research Foundation
11 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use birth control during and for 6 months after the study if my partner can get pregnant.I am not pregnant or breastfeeding and use effective birth control.My Parkinson's disease is advanced, leaving me severely disabled or unable to leave my bed or wheelchair.I do not plan to donate sperm during or within 6 months after the study.I have hepatitis B, C, or HIV.I take less than 1400 mg of Levodopa or its equivalent daily.I am not pregnant and do not plan to become pregnant during the study and for 6 months after.I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.I take less than 1200 mg of Carbidopa/Levodopa daily.I haven't taken antibiotics, antivirals, or antifungals for an infection in the last 30 days.I do not plan to donate eggs or have IVF within 6 months after the last dose.I am willing and able to follow the clinical trial's requirements.I have not had any stem cell treatments in the last 6 months, except those from Hope Biosciences.I was diagnosed with Parkinson's disease at least 2 years ago.I am between 45 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Allogeneic HB-adMSCs.
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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