Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Chronic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064957
Expanded Access Status : No longer available
First Posted : August 22, 2019
Last Update Posted : July 6, 2021
Sponsor:
Collaborator:
Hope Biosciences
Information provided by (Responsible Party):
Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )

Tracking Information
First Submitted Date August 19, 2019
First Posted Date August 22, 2019
Last Update Posted Date July 6, 2021
 
Descriptive Information
Brief Title Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Chronic Spinal Cord Injury
Official Title Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cell Therapy for Chronic Spinal Cord Injury
Brief Summary 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).
Detailed Description

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
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Spinal Cord Injuries
Intervention Biological: HB-adMSCs
Other Name: Hope Biosciences autologous adipose-derived mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04064957
Other Study ID Numbers HBSCI02
Responsible Party Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )
Study Sponsor Hope Biosciences Stem Cell Research Foundation
Collaborators Hope Biosciences
Investigators Not Provided
PRS Account Hope Biosciences
Verification Date August 2019