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

Spinal Cord Injury at C5-C7 Level Clinical Trial

Official title:

Individual Patient Expanded Access IND (Investigational New Drug) of Autologous HB-adMSCs for the Treatment of Spinal Cord Injury

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03925649
• Other study ID #: HBSCI01
• Status: No longer available

Study information

• Verified date: August 2019
• Source: Hope Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury at C5-C7 Level

Intervention

Biological:
• HB-adMSCs
single infusion of HB-adMSCs

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital-Clinical Research Unit (MMH-CRU)	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Hope Biosciences	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States,