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

NCT04029896 | Unknown

• 1 other identifier: HBCP01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

CP; stem cells; MSCs; spastic; paralysis; cerebral palsy

Interventions

HB-adMSCs BIOLOGICAL

intravenous infusion of Hope Biosciences autologous adipose-derived stem cells

Eligibility Criteria

• Age: 3 Years+
• Sex: male
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cerebral Palsy
• 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.

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

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Paralysis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)