Intermediate Size Expanded Access Protocol Using Autologous HB-adMSCs for the Treatment of Parkinson's Disease

NCT06056427 | Unknown

• 1 other identifier: HBPD06
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This expanded access protocol is part of IND 027396 to evaluate efficacy and safety of multiple intravenous administrations of autologous HB-adMSCs for the treatment of Parkinson's disease for up to 11 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBPD03 clinical study protocol entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.

Conditions

Parkinson Disease

Interventions

HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells) BIOLOGICAL

Participants will receive autologous HB-adMSCs through intravenous infusion only, with a treatment duration of 18 weeks, infusion rate 4-5mL/min and total volume of 250 mL Sodium chloride 0.9%. Each participant will receive a total of 6 doses of HB-adMSCs with a dosing regimen of approximately 2 weeks between infusion 1 and infusion 2, and 4 weeks between the remaining infusions.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have passed pre-screening for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
• Patients must have screened for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
• Patients must have not been randomized into the treatment group for the HBPD03 clinical trial entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
• Male and female participants 18 - 80 years of age.
• Patients must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before participation.
• Patients must have previously banked their mesenchymal stem cells with Hope Biosciences.
• Patients should be able to read, understand and to provide written consent.
• Voluntarily signed informed consent obtained before any expanded access-related procedures are performed.
• Female patients should not be pregnant or plan to become pregnant during participation and for 6 months after last investigational product administration.
• Male patients if their sexual partners can become pregnant should use a method of contraception during participation and for 6 months after the last administration of the investigated product.
• Patient is able and willing to comply with the requirements of this Expanded Access.

You may not qualify if:

• Patients with advanced Parkinson's disease. Advanced PD is defined as a significant disability, wheelchair-bound or bedridden.
• Any malignancy or clinical evidence that supports the presence of a malignant process in a patient is being investigated. Malignancy is defined as any form of cancer that had occurred in the previous five years before the first infusion and may require surgery, chemotherapy, or radiation.
• Patients with medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure \> 150/90 mm/Hg during screening visit.
• Patients with the following concomitant or past medical history:
• Heart Failure - New York Heart Association (NYHA) Class III/IV.
• Heart Attack (in the past six months before 1st infusion).
• Stroke (in the past six months before 1st infusion).
• Hepatitis B or C.
• Human immunodeficiency virus (HIV) infection.
• Any of the following abnormal lab findings during screening will disqualify a patient from this expanded access protocol:
• Hemoglobin (Hgb) \<10 G/DL or \>18 G/DL
• Hematocrit (HCT) \<30% or \>55%
• Platelet count \< 80 K/UL and or \> 450 K/UL.
• White blood cell count WBC \< 3.0 K/UL and \> 13.0 K/UL.
• Alanine aminotransferase (ALT) of \> 75 IU/L

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Last Updated: September 29, 2025

Record last verified: 2025-09