What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include medications like levodopa, dopamine agonists, COMT inhibitors, and MAO-B inhibitors. Levodopa can cause side effects such as nausea, dizziness, and dyskinesia (involuntary movements). Dopamine agonists may lead to sleepiness, hallucinations, and impulse control disorders. COMT inhibitors can cause diarrhea and urine discoloration, while MAO-B inhibitors may result in headaches and joint pain. For treatments similar to allogeneic HB-adMSCs, such as other stem cell therapies, potential side effects include immune reactions, infections, and the risk of tumor formation. These therapies are still under investigation, and their long-term safety and efficacy are not yet fully established.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on symptom management rather than cell repair or immune modulation. These include medications like Levodopa, which is often combined with Carbidopa to enhance its efficacy, and dopamine agonists such as Pramipexole and Ropinirole. Additionally, MAO-B inhibitors like Selegiline and Rasagiline are used to slow the breakdown of dopamine in the brain. While these treatments do not directly repair or replace damaged cells, they help manage the symptoms of Parkinson's Disease. There is limited information on FDA-approved treatments specifically involving stem cell therapies or immune modulation similar to the Allogeneic HB-adMSCs being studied.

What other types of research exist?

Promising alternatives to Allogeneic HB-adMSCs for Parkinson's Disease patients include: 1) Intraspinal neural stem cell transplantation, which has shown potential in ALS and could be applicable to PD. 2) Mesenchymal stem cells secreting neurotrophic factors, which have demonstrated safety and clinical effects in ALS. 3) Autologous hematopoietic stem cell transplantation, which has been explored in multiple sclerosis and may offer benefits for PD. These therapies are in various stages of clinical trials and could provide novel treatment options for PD patients.

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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 8, 16, 24, 32, 42 and 52.

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I take less than 1200 mg of Carbidopa/Levodopa daily.

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I am between 45 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My Parkinson's disease is advanced, leaving me severely disabled or unable to leave my bed or wheelchair.

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I do not plan to donate sperm during or within 6 months after the study.

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I have hepatitis B, C, or HIV.

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I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.

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I haven't taken antibiotics, antivirals, or antifungals for an infection in the last 30 days.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 8, 16, 24, 32, 42 and 52. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

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%

0 / 9Eligibility criteria met

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.