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

Hope Biosciences

Status

Conditions: Spinal Cord Injury at C5-C7 Level

Treatments: Biological: HB-adMSCs

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT03925649

HBSCI01

Details and patient eligibility

About

This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)

Full description

This is an expanded access single-dose study with the primary goal of treatment submitted at the request of an individual patient with complete C5-6 spinal cord injury (SCI) resulting in quadriplegia who does not qualify for any current clinical trials and for whom there are no other FDA approved fully restorative treatments. The overall objective of this study is to evaluate patient's response, adverse events and serious adverse events (AE/SAEs), and cell expansion characteristics of a single intravenous (IV) infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in a subject with complete SCI resulting in quadriplegia.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cognitively intact, capable of giving informed consent
• Clinical diagnosis of a non-penetrating traumatic SCI
• Asia Impairment Scale grade of A, B, or C

Exclusion criteria

1. Prior history of:

   • Brain injury
   • Recent or ongoing infection
   • Clinically significant cardiovascular, lung, renal, hepatic or endocrine disease,
   • Neurodegenerative disorders
   • Cancer
   • Immunosuppression as defined by WBC<3,000 cells/ml at baseline screening,
   • HIV+
   • Chemical or ETOH dependency

2. Having a contraindication to MRI scans

3. 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

4. Participation in other interventional research studies

5. Unwillingness to return for follow-up visits