Intermediate Size Patient Population Expanded Access IND for the Treatment of Patients With Parkinson's Disease.

NCT04772378 | Unknown

• 1 other identifier: HBPD05
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This Expanded Access IND is to evaluate the safety of multiple intravenous administrations of HB-adMSCs for treating Parkinson's disease in 10 patients between 76 and 95 y/o who do not qualify for other investigations.The dose to use for this expanded access is 200 million HB-adMSCs, administered through intravenous infusion only, with a treatment duration of 18 weeks. The program includes an up to 28 days screening period, an 18-week Treatment Period, and a 6-week Safety Follow-up Period.

Conditions

Parkinson Disease

Keywords

Mesenchymal Stem Cells; Parkinson's Disease; MSCs; Stem Cells; Neurodegenerative; Parkinson

Interventions

HB-adMSCs BIOLOGICAL

HB-adMSCs (Hope Biosciences autologous adipose-derived mesenchymal stem cells) is manufactured by Hope Biosciences, L.L.C., a biotechnology company headquartered in Sugar Land, Texas.

Eligibility Criteria

• Age: 76 Years - 95 Years
• Sex: all
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 76-95 years old (male and female).
• Patients must have had a Parkinson's disease diagnosis for a minimum of six months before 1st infusion.
• Patients must have previously banked their mesenchymal stem cells with Hope Biosciences.
• Patients should be able to read, understand, and provide voluntarily written consent.
• Patients able and willing to comply with the requirements of this expanded access program.

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 \> 140/90 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 program:
• Hemoglobin (Hgb) \<10 G/DL or \>18 G/DL
• Hematocrit (HCT) \<30% or \>54 %
• Platelet count \< 80 K/UL and or \> 450 K/UL.
• White blood cell count WBC \< 3.0 K/UL and \> 12.0 K/UL.
• Alanine aminotransferase (ALT) of \> 75 IU/L

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

Related Links

• Hope Biosciences Stem Cell Research Foundation

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 Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)