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出境医 / 临床实验 / 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 Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for the Treatment of Cerebral Palsy

Study Description
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 Drug: 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
Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Eligibility Criteria
Contacts and Locations
Tracking Information
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:

  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
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
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. 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.
Sex/Gender
Sexes Eligible for Study: Male
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