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 Stem Cell 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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether special cells from human fat tissue can help treat Parkinson's disease. The study involves patients with Parkinson's who will receive these cells. The goal is to see if these cells can repair or protect brain cells and improve symptoms. These cells have shown promise in animal models for treating Parkinson's disease.

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.

What safety data exists for stem cell therapy in Parkinson's disease?

The safety data for stem cell therapy in Parkinson's disease includes a case report of a 77-year-old female patient who received 26 infusions of autologous Hope Biosciences adipose-derived mesenchymal stem cells (HB-adMSCs) over two years, which were safely tolerated without any serious adverse events. Additionally, animal studies have shown that mesenchymal stem cells, including adipose-derived ones, have a positive impact on motor function and memory, and protect dopaminergic neurons, suggesting a promising safety profile. However, further research is needed to fully evaluate the safety and efficacy of these therapies in humans. ^{1 2 3 4 5}

Is stem cell therapy safe for humans with Parkinson's disease?

In a case report, a 77-year-old woman with Parkinson's disease safely received multiple infusions of adipose-derived mesenchymal stem cells over two years without any serious side effects. ^{1 2 3 4 5}

Is the treatment Allogeneic HB-adMSCs, Placebo a promising treatment for Parkinson's Disease?

Yes, Allogeneic HB-adMSCs, also known as adipose-derived mesenchymal stem cells, show promise as a treatment for Parkinson's Disease. Research indicates that these stem cells can improve motor functions, protect brain cells, and release helpful substances that support brain health. They have been shown to improve symptoms in both human and animal studies, making them a promising option for further exploration. ^{1 3 6 7 8}

How is the treatment Allogeneic HB-adMSCs for Parkinson's disease different from other treatments?

Allogeneic HB-adMSCs (adipose-derived mesenchymal stem cells) are unique because they use stem cells from fat tissue to potentially replace damaged neurons and release protective factors, offering a novel approach compared to traditional treatments that mainly manage symptoms without addressing neuron loss. ^{1 3 6 7 8}

What data supports the idea that Stem Cell Therapy for Parkinson's Disease is an effective treatment?

The available research shows that Stem Cell Therapy, specifically using mesenchymal stem cells, has shown promising results in treating Parkinson's Disease. In a case report, a 77-year-old woman with Parkinson's Disease experienced significant improvements in her symptoms after receiving multiple infusions of stem cells over two years. In animal studies, stem cell treatments improved motor functions and protected brain cells that are typically damaged in Parkinson's Disease. These studies suggest that stem cell therapy could be a beneficial treatment option for Parkinson's Disease, although more research is needed to confirm its effectiveness and safety. ^{1 3 6 8 9}

What data supports the effectiveness of the treatment Allogeneic HB-adMSCs for Parkinson's Disease?

Research shows that mesenchymal stem cells, like those used in the treatment, have improved motor function and protected brain cells in animal models of Parkinson's Disease. A case report also noted improvements in a patient's symptoms after receiving similar stem cell therapy. ^{1 3 6 8 9}

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 Stem Cell Research Foundation

Lead Sponsor

Trials

22

Recruited

340+

Hope Biosciences

Industry Sponsor

Trials

27

Recruited

470+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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. United States 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. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Intravenous mesenchymal stem cell administration exhibits therapeutic effects against 6-hydroxydopamine-induced dopaminergic neurodegeneration and glial activation in rats. [2014]

3. Switzerland 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. [2023]

4. India 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. [2023]

5. England 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. [2015]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Autologous mesenchymal stem cell-derived dopaminergic neurons function in parkinsonian macaques. [2021]

8. United States 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. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell therapy in Parkinson's disease animal models. [2022]