- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029896
Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy
Individual Patient Expanded Access IND of Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy
Study Overview
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:
- Interval H&P update,
- Weight
- Vital signs monitoring (Heart Rate, BP, Resp., Temp., SpO2),
- A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel, Serum Leptin),
- A verification of patient/LAR consent will be verbally performed,
- The HB-adMSC infusion will be given via IV over a 1 hour period.
- The subject will then be monitored for a minimum of 4hr.
- 24-hour telephone assessment for adverse events
- 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:
- Review and update medical history,
- Update concomitant medications list
- Video documentation
- Weight
- Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
- Physical exam,
- A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel and serum leptin)
- SARAH assessment on Weeks 4, 12 and 16.
- 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)
- Review and update medical history,
- Update concomitant medications list
- Weight
- Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
- Physical exam,
- A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel and serum leptin),
- Chest X ray (PA Single view)
- The SARAH (motor-functional evaluation scale for children and adolescents with cerebral palsy)
- Adverse event monitoring
- Video documentation
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Locations
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Texas
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Sugar Land, Texas, United States, 77478
- Hope Biosciences Stem Cell Research Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Cerebral Palsy
- 3 years and older.
Exclusion Criteria:
- Recent or ongoing infection
- Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease.
- Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening.
- 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.
- Participation in other interventional research studies.
- Unwillingness to return for follow-up visits.
Study Plan
How is the study designed?
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBCP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
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MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
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East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
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October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
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Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
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