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

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ClinicalTrials.gov Identifier: NCT04029896
Expanded Access Status : No longer available
First Posted : July 23, 2019
Last Update Posted : July 6, 2021
Sponsor:
Collaborator:
Hope Biosciences
Information provided by (Responsible Party):
Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )

Brief Summary:
This is an Individual Patient Expanded Access Protocol of Autologous HB-adMSCs for the Treatment of Cerebral Palsy (CP) with the primary goal of treating 1 individual with CP who has exhausted all treatment options, his condition has not improved, his quality of life is severely affected by the condition and he has previously banked his mesenchymal stem cells. There are no FDA approved, fully restorative treatments for CP. The subject will receive 8 autologous HB-adMSC infusions of 50 million (50 x 10^6 cells) total cells. A protocol amendment to administer additional HB-adMSC infusions may be submitted for IRB/FDA for approval depending on the patient's response, AE/SAEs, and cell expansion characteristics.

Condition or disease Intervention/treatment
Cerebral Palsy Biological: HB-adMSCs

Detailed Description:

Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline visit, the subject will return for the first infusions. Subsequent treatments will occur every other week.

On each of these visits, the subject will receive one autologous HB-adMSC infusion of 50 million (50 x 10^6 cells) total cells. Every infusion visit will include the following procedures:

  1. Interval H&P update,
  2. Weight
  3. Vital signs monitoring (Heart Rate, BP, Resp., Temp., SpO2),
  4. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel, Serum Leptin),
  5. A verification of patient/LAR consent will be verbally performed,
  6. The HB-adMSC infusion will be given via IV over a 1 hour period.
  7. The subject will then be monitored for a minimum of 4hr.
  8. 24-hour telephone assessment for adverse events
  9. Video Documentation

Follow Up Visits Week 4, 8, 12 and 16 (Safety Assessments)

The patient will be assessed for adverse events 24 hours after each infusion with a follow up phone call. 4 weeks after the first infusion have occurred, the subject will return to the clinical site for an onsite safety assessment, which will be repeated at week 8, 12, and 16. Each one of these on-site safety assessments will include:

  1. Review and update medical history,
  2. Update concomitant medications list
  3. Video documentation
  4. Weight
  5. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
  6. Physical exam,
  7. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel and serum leptin)
  8. SARAH assessment on Weeks 4, 12 and 16.
  9. Adverse event monitoring Follow Up Visit Week 26 (Safety Assessments)

1. Review and update medical history, 2. Update concomitant medications list 3. Weight 4. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2), 5. Physical exam, 6. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel and serum leptin), 7. Brain MRI 8. The SARAH (motor-functional evaluation scale for children and adolescents with cerebral palsy) 9. Adverse event monitoring 10. Video documentation

Follow Up Visit Week 52 (Safety Assessments-End of Study)

  1. Review and update medical history,
  2. Update concomitant medications list
  3. Weight
  4. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
  5. Physical exam,
  6. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel and serum leptin),
  7. Chest X ray (PA Single view)
  8. The SARAH (motor-functional evaluation scale for children and adolescents with cerebral palsy)
  9. Adverse event monitoring
  10. Video documentation

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Individual Patient Expanded Access IND of Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: HB-adMSCs
    intravenous infusion of Hope Biosciences autologous adipose-derived stem cells

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Criteria

Inclusion Criteria:

  1. Diagnosis of Cerebral Palsy
  2. 3 years and older.

Exclusion Criteria:

  1. Recent or ongoing infection
  2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease.
  3. Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening.
  4. 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.
  5. Participation in other interventional research studies.
  6. Unwillingness to return for follow-up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029896


Locations
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United States, Texas
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States, 77478
Sponsors and Collaborators
Hope Biosciences Stem Cell Research Foundation
Hope Biosciences
Additional Information:
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Responsible Party: Hope Biosciences Stem Cell Research Foundation
ClinicalTrials.gov Identifier: NCT04029896    
Other Study ID Numbers: HBCP01
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: October 2020
Keywords provided by Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation ):
CP
stem cells
MSCs
spastic
paralysis
cerebral palsy
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases