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

NCT04772378 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-09-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

HB-adMSCs

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.

Sponsors & Collaborators

  • Hope Biosciences Research Foundation

    lead INDUSTRY

Principal Investigators

  • Djamchid Lotfi, MD · Hope Biosciences Stem Cell Research Foundation

Eligibility

Min Age
76 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04772378 on ClinicalTrials.gov