Condition or disease | Intervention/treatment |
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Cerebral Palsy | Drug: HB-adMSCs |
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:
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. 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)
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 |
Tracking Information | |||
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First Submitted Date | July 19, 2019 | ||
First Posted Date | July 23, 2019 | ||
Last Update Posted Date | March 25, 2021 | ||
Descriptive Information | |||
Brief Title | Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy | ||
Official Title | Individual Patient Expanded Access IND of Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy | ||
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. | ||
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:
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. 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)
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Study Type | Expanded Access | ||
Expanded Access Type | Individual Patients | ||
Condition | Cerebral Palsy | ||
Intervention | Drug: HB-adMSCs
intravenous infusion of Hope Biosciences autologous adipose-derived stem cells
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Expanded Access Status | No longer available | ||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 3 Years and older (Child, 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 | NCT04029896 | ||
Other Study ID Numbers | HBCP01 | ||
Responsible Party | Hope Biosciences | ||
Study Sponsor | Hope Biosciences | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | Hope Biosciences | ||
Verification Date | October 2020 |