Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Chronic Spinal Cord Injury
Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Chronic Spinal Cord Injury
This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request
 submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about
 4:30pm, slipped off a boat head-first while in the Florida Keys for a family wedding, and was
 immediately unable to move his legs. He was emergently transferred to Miami, FL for
 stabilization and treatment, where he was diagnosed with a C5 -C6 Grade 2 anterolisthesis of
 C5 on C6: 7mm, with flexion teardrop fracture of the anterior aspect of C6, as well as jumped
 facet on the right and perched facet on the left at C5-C6 with spinal canal stenosis with
 cord compression, as well as with aspiration and near drowning. He underwent ACDF (anterior
 cervical discectomy and fusion) of C5-C6 and reduction of jumped facets and was immediately
 started on a hypothermia protocol to reduce spinal cord edema. His hospital course was
 complicated by aspiration pneumonia. He discharged to Texas via air ambulance for physical
 rehabilitation on August 23, 2017 with a diagnosis of ASIA B (American Spinal Injury
 Association) C-5 SCI (spinal cord injury).
Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline
 visit, the subject will receive the first infusion. Subsequent treatments will occur every
 other week in the subject's home, administered by a nurse.

 On each of these visits, the subject will receive one autologous HB-adMSC infusion of 200
 million (2 x 10^8 cells) total cells. Every infusion visit will include the following
 procedures:

 1. Interval H&P and concomitant medications update utilizing the secure VirTrial platform.

 2. QOL and Disability (SCIM self eval) surveys will be completed by the subject with the
 assistance of the primary caregiver.

 3. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),

 4. A peripheral IV line will be inserted,

 5. A blood sample for clinical labs (CBC with Platelets, CMP, PT, PTT, TNFa, IL6, CRP) will
 be drawn monthly during the infusion period.

 6. A "time out" verification of patient/consent/procedure/cell product will be performed,

 7. The HB-adMSC infusion will be given by through the peripheral IV, infused over 1 hour at
 a rate of 250ml/hr (83gtts/minute) by a registered nurse.

 8. Assessment for Infusion Related AE/SAEs

 9. The subject will be monitored for a minimum of 2 hours

 In-Person Visits The subject will return to the Clinical Trial Network CTN site for In-Person
 visits to occur at Screening, Baseline and Week twelve (12), twenty-six (26) and at Week
 fifty-two (52). Week 52 visit will serve as the End of Study visit. The end of study (EOS)
 visit will include an MRI of the c-spine as well as all of the study procedures for Follow-up
 Visits without Infusion. A written summary of the results of the treatment, including adverse
 events will be submitted to the FDA after completion of the last follow-up visit.

 Visits without infusion will include:

 1. Interval H&P and concomitant medications update.

 2. QOL and Disability (SCIM self eval) surveys will be completed by the subject with the
 assistance of the primary caregiver.

 3. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),

 4. A Physical and Neuro Exam (Asia Impairment Scale) will be completed

 5. A blood sample for clinical labs (CBC with Platelets, CMP, PT, PTT, TNFa, IL6, CRP) will
 be drawn.

 6. Video documentation of patient condition.

 7. Assessment for infusion related AEs/SAEs

 8. Weight
Inclusion Criteria:

 1. Adult individual 18 yr. of age or older.

 2. Cognitively intact and capable of giving informed consent.

 3. Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine

 4. Patient and Caregiver agree to use Care Connect app or web version of VirTrial
 platform for virtual visits.

 Exclusion Criteria:

 1. Prior history of:

 1. Recent or ongoing infection,

 2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine
 disease,

 3. Neurodegenerative disorders,

 4. Cancer,

 5. Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening,

 6. 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