Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy

NO_LONGER_AVAILABLE

Conditions studied: Cerebral Palsy

In brief

This is an Individual Patient Expanded Access Protocol of Autologous HB-adMSCs for the Treatment of Cerebral Palsy (CP) with the primary goal of treating 1 individual with CP who has exhausted all treatment options, his condition has not improved, his quality of life is severely affected by the condition and he has previously banked his mesenchymal stem cells. There are no FDA approved, fully restorative treatments for CP. The subject will receive 8 autologous HB-adMSC infusions of 50 million (50 x 10\^6 cells) total cells. A protocol amendment to administer additional HB-adMSC infusions may be submitted for IRB/FDA for approval depending on the patient's response, AE/SAEs, and cell expansion characteristics.

Key facts

Study ID

NCT04029896

Run by

Hope Biosciences Research Foundation

Last updated by the study team

2025-09-29

Who can join

Age: 3 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Cerebral Palsy
• 3 years and older.

You may not qualify if…

• Recent or ongoing infection
• Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease.
• Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening.
• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration.
• Participation in other interventional research studies.
• Unwillingness to return for follow-up visits.

Where it is running

• Hope Biosciences Stem Cell Research Foundation — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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