Individual Patient Expanded Access IND for the Treatment of Stroke

NCT04907188 | Unknown

• 1 other identifier: HBSK01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol is part of an Individual Patient Expanded Access IND. The patient is an 84-year-old male with history of Ischemic Stroke of the Left Middle Cerebral Artery causing an acute posterior left frontal cortical infarct with petechial hemorrhage and mild local mass effect without midline shift. The Stroke was due to a long-standing evolution of atrial fibrillation that provoked an embolus. The original stroke event happened on February/14/2022.

Conditions

Stroke; Stroke, Ischemic

Keywords

Stroke; Ischemic; Mesenchymal Stem Cells; MSCs; Stem Cells

Interventions

HB-adMSCs BIOLOGICAL

The subject will receive 6 autologous HB-adMSCs intravenous infusion of 200 million (2 x 10\^8 cells) cells approximately every 28 days.

Also known as: MSCs

Eligibility Criteria

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

You may qualify if:

• Documented diagnosis Stroke.
• Hemodynamically stable.

You may not qualify if:

• Any signs of active infection at the time of screening.
• Subjects with coagulation disorders.
• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
• Any abnormal, inexplicable laboratory result with no obvious cause defined.
• 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

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: May 26, 2021
• First Posted: May 28, 2021
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)