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

September 24, 2025 updated by: Hope Biosciences Research Foundation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Sugar Land, Texas, United States, 77478
        • Hope Biosciences Stem Cell Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hope Biosciences Research Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hope Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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