Stem Cell Therapy for Parkinson's Disease

(HBPD04 Trial)

Overseen By Michelle C Biedron, DNP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hope Biosciences Research Foundation

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Advanced Parkinson's, Active malignancy, Alcohol addiction, Poorly controlled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stem cell treatment to determine its effectiveness for people with Parkinson's disease. Researchers aim to assess whether the stem cells (Allogeneic HB-adMSCs) can improve symptoms and are safe compared to a placebo (inactive substance). Participants will receive either the stem cells or a placebo intravenously. Suitable participants should have been diagnosed with early or moderate Parkinson's for at least two years and should not have advanced symptoms, such as being wheelchair-bound. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, your Carbidopa/Levodopa dosage must be less than 1200 mg per day, and the total Levodopa equivalent dose must be less than 1400 mg per day.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your Carbidopa/Levodopa dosage is less than 1200 mg per day and the total Levodopa equivalent dose is less than 1400 mg per day.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that stem cells taken from fat tissue, known as allogeneic HB-adMSCs, might be safe for treating Parkinson's disease. Studies have found that these stem cells are usually well-tolerated, with few serious side effects. Most people experience only mild reactions, such as slight headaches or temporary tiredness.

Previous patients using these stem cells for Parkinson's have not shown any major safety concerns, suggesting the treatment may be safe for more people. However, individual experiences can vary, so discussing options with healthcare professionals is important for personalized advice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Researchers are excited about Allogeneic HB-adMSCs for Parkinson's Disease because they offer a novel approach by using stem cells derived from adipose (fat) tissue. Unlike current treatments, which often focus on managing symptoms through medications like levodopa or dopamine agonists, this therapy aims to potentially repair or regenerate damaged brain cells. The unique delivery method, via intravenous administration, targets the disease at a cellular level, which could lead to improved outcomes and reduced progression of the disease. This innovative approach represents a significant shift from merely addressing symptoms to potentially altering the course of Parkinson's Disease.

What evidence suggests that this treatment might be an effective treatment for Parkinson's disease?

Research suggests that stem cells from donors, known as allogeneic HB-adMSCs, might improve symptoms in people with Parkinson's disease. In this trial, some participants will receive allogeneic HB-adMSCs, which previous studies have shown to provide lasting improvements. These stem cells can develop into different types of tissues and may help by reducing inflammation and aiding brain repair. Other research has found that this treatment is safe and well-tolerated in older patients. Overall, early findings indicate potential benefits, but more research is needed to confirm its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Djamchid Lotfi

Principal Investigator

Hope Biosciences Stem Cell Research Foundation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I will use birth control during and for 6 months after the study if my partner can get pregnant.

Study participants must have an MDS-UPDRS part III score between 20 and 57 during the screening visit

I take less than 1400 mg of Levodopa or its equivalent daily.

Exclusion Criteria

Study participant has 1 or more significant concurrent medical conditions (verified by medical records)

Study participant has a laboratory abnormality during screening

I am not pregnant or breastfeeding and use effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive multiple infusions of allogeneic HB-adMSCs or placebo over a 32-week period

32 weeks

7 visits (in-person), 2 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Allogeneic HB-adMSCs
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Allogeneic HB-adMSCs. Active Control 2 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: Placebo Placebo Group 2 Interventions

Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9%

Who Is Running the Clinical Trial?

Hope Biosciences Research Foundation

Lead Sponsor

Hope Biosciences Stem Cell Research Foundation

Lead Sponsor

Trials

22

Recruited

340+

Hope Biosciences

Industry Sponsor

Trials

27

Recruited

470+

Published Research Related to This Trial

Transplantation of adult bone-marrow mesenchymal stem cells in a rat model of Parkinson's disease significantly reduced rotational behavior by 50% compared to control groups, indicating a potential therapeutic effect.

The grafting of these stem cells not only improved behavior but also led to a notable increase in dopaminergic markers in the brain, suggesting that this cellular therapy could help restore dopamine levels in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial recovery of dopaminergic pathway after graft of adult mesenchymal stem cells in a rat model of Parkinson's disease. Bouchez, G., Sensebé, L., Vourc'h, P., et al.[2015]

A 77-year-old woman with Parkinson's disease experienced significant improvements in her symptoms after receiving 26 infusions of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) over approximately 2 years, as indicated by reduced UPDRS scores.

The treatment was well-tolerated with no serious adverse events reported, suggesting that HB-adMSC therapy may be a safe option for managing Parkinson's disease, although further research is necessary to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term, repeated doses of intravenous autologous mesenchymal stem cells for a patient with Parkinson's disease: a case report. Vij, R., Prossin, A., Tripathy, M., et al.[2023]

Transplanting monolayer-cultured adipose-derived mesenchymal stem cells (aMSC) into the substantia nigra of Parkinson's disease model rats improved motor functions and increased neuroprotective factors like tyrosine hydroxylase and brain-derived neurotrophic factor.

In contrast, spheroid-cultured mesenchymal stem cells (sMSC) led to negative effects, such as increased microgliosis and decreased levels of neuroprotective factors, highlighting that the effectiveness of stem cell therapy depends on the cellular phenotype used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human adipose-derived mesenchymal stem cells improve motor functions and are neuroprotective in the 6-hydroxydopamine-rat model for Parkinson's disease when cultured in monolayer cultures but suppress hippocampal neurogenesis and hippocampal memory function when cultured in spheroids. Berg, J., Roch, M., Altschüler, J., et al.[2021]

In a study using a hemi-parkinsonian rat model, intravenous administration of human bone marrow-derived mesenchymal stem cells (hBM-MSCs) significantly improved motor function and preserved dopaminergic neurons over a 28-day period after treatment.

The results suggest that hBM-MSCs may offer a novel therapeutic approach for Parkinson's disease by promoting the survival of neurons affected by the disease, indicating potential for future clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mesenchymal stem cell administration exhibits therapeutic effects against 6-hydroxydopamine-induced dopaminergic neurodegeneration and glial activation in rats. Suzuki, S., Kawamata, J., Iwahara, N., et al.[2014]

Adipose-derived stem cells (ADSCs) significantly improve motor function in animal models of Parkinson's disease, as shown by enhanced rotation behavior and rotarod performance in 10 studies involving 169 animals.

The therapy appears to have long-lasting effects, likely due to neurogenesis from neuronally differentiated ADSCs, with a notable recovery of tyrosine hydroxylase-positive neurons in the affected areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and mechanisms of adipose-derived stem cell therapy in animal models of Parkinson's disease: a systematic review and meta-analysis. Li, K., Li, X., Shi, G., et al.[2021]

Transplanting A9 dopaminergic neuron-like cells derived from mesenchymal stem cells (MSCs) into the striatum of hemiparkinsonian macaques led to long-term survival of the cells and gradual restoration of motor function, indicating potential efficacy for Parkinson's disease treatment.

The study demonstrated that these transplanted cells expressed dopamine transporter markers and released dopamine, with PET imaging showing sustained increases in dopamine transporter expression for over 7 months, suggesting a safe and effective mechanism of action for the cell therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous mesenchymal stem cell-derived dopaminergic neurons function in parkinsonian macaques. Hayashi, T., Wakao, S., Kitada, M., et al.[2021]

Mesenchymal stem cell therapy significantly improved motor function and protected dopaminergic neurons in a meta-analysis of 33 studies involving 840 Parkinson's disease model animals, with the most effective results seen from bone marrow-derived stem cells combined with neurotrophic factors.

The treatment not only enhanced motor skills, as measured by the amphetamine-induced rotational test, but also showed potential for improving memory function, particularly when administered intravenously, indicating a multifaceted therapeutic benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mesenchymal stem cell on dopaminergic neurons, motor and memory functions in animal models of Parkinson's disease: a systematic review and meta-analysis. Park, JM., Rahmati, M., Lee, SC., et al.[2023]

Pre-exposing human adipose-derived mesenchymal stem cells (hAMSCs) to glial cell line-derived neurotrophic factor (GDNF) significantly enhances their proliferation and differentiation, which could improve their effectiveness in treating Parkinson's disease (PD).

In a mouse model of PD, hAMSCs treated with GDNF showed better behavioral performance and larger graft volumes after transplantation compared to untreated hAMSCs, indicating that GDNF can enhance the therapeutic potential of stem cell therapies for PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GDNF Promotes Survival and Therapeutic Efficacy of Human Adipose-Derived Mesenchymal Stem Cells in a Mouse Model of Parkinson's Disease. Sun, S., Zhang, Q., Li, M., et al.[2021]

Mesenchymal stem cells (MSCs) show promise as a novel therapy for Parkinson's disease due to their ability to differentiate into dopaminergic neurons and release beneficial neurotrophic factors.

These stem cells can be sourced from various tissues, including bone marrow and adipose tissue, and have demonstrated immunomodulatory and neuroprotective effects in animal models of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy in Parkinson's disease animal models. Gugliandolo, A., Bramanti, P., Mazzon, E.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04995081

Clinical Trial for Parkinson's Disease Using Allogeneic HB ... The trial includes 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 ...

2. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04577-y

secondary results of a Parkinson's disease clinical trial | Stem ... Allogeneic bone marrow-derived mesenchymal stem cells in the aging kidney: secondary results of a Parkinson's disease clinical trial. Juan D.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12154328/

Tissue Stem Cell-Based Therapies in Parkinson's Disease Moreover, some studies report lasting improvements in PD symptoms, with transplanted mesenchymal stem cells (MSCs) and human adipose-derived ...

4. ctv.veeva.com ctv.veeva.com/study/clinical-trial-for-parkinsons-disease-using-allogeneic-hb-admscs-early-and-moderate-pd

Clinical Trial for Parkinson's Disease Using Allogeneic HB ... 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39425736/

Safety and efficacy of adipose-derived mesenchymal stem ... The administration of autologous 200MM HB-adMSCs was found to be safe and well-tolerated in the elderly PD population.

6. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/abs/10.1002/mds.70028

Allogeneic Bone Marrow‐Derived Mesenchymal Stem Cells ... Repeated intravenous infusion of autologous adipose-derived stem cells improves cognitive function. Alzheimers Dement 2021; 17(Suppl. 9): ...

7. withpower.com withpower.com/trial/phase-3-parkinson-disease-6-2021-ba64c

Stem Cell Therapy for Parkinson's Disease (HBPD04 Trial) Yes, Allogeneic HB-adMSCs, also known as adipose-derived mesenchymal stem cells, show promise as a treatment for Parkinson's Disease. Research indicates that ...