Studies
| Study First Submitted Date | 2021-03-25 |
| Study First Posted Date | 2021-04-01 |
| Last Update Posted Date | 2022-09-22 |
| Verification Month Year | September 2022 |
| Verification Date | 2022-09-30 |
| Last Update Posted Date | 2022-09-22 |
Detailed Descriptions
| Sequence: | 20559363 |
| Description | An informed consent form will be given to the participant, who will sign before any procedures. The informed consent form will include information about this expanded access and all the aspects considered during this process. The participant is required to complete the subsequent visits after they have given their informed consent. Visit 1 – Screening during this period, the principal investigator will determine whether the screened participant is eligible and whether the next visit can be scheduled. Once the principal investigator has evaluated the eligibility (up to 28 days), the patient will be scheduled for the first infusion. Visit 2 – Infusion 1 (Baseline): this visit will be a starting point for comparing participant's data. During this visit, the patient will receive the 1st investigational product via intravenous infusion, with rigorous monitoring of vital signs for a total of 2 hours. Visit 3 to 12 – During these visits, the patient will receive intravenous infusions of HB- adMSCs while her vital signs are precisely monitored for a total of 2 hours. Follow-Up Phone Call – During this safety follow-up phone call, the principal investigator will evaluate the safety of the investigational product by conducting several assessments described in the Schedule of Assessments table. End of Study – At the end of the expanded access program visit, the principal investigator will conduct various evaluations to determine the patient's physical condition and assess whether there have been any safety events resulting from the participation in the expanded access program. |
Facilities
| Sequence: | 198498697 |
| Name | Hope Biosciences Stem Cell Research Foundation |
| City | Sugar Land |
| State | Texas |
| Zip | 77478 |
| Country | United States |
Conditions
| Sequence: | 51754337 |
| Name | Chronic Inflammatory Demyelinating Polyneuropathy |
| Downcase Name | chronic inflammatory demyelinating polyneuropathy |
Id Information
| Sequence: | 39825544 |
| Id Source | org_study_id |
| Id Value | HBCIDP01 |
Countries
| Sequence: | 42225620 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52075719 |
| Intervention Type | Biological |
| Name | HB-adMSCs |
| Description | Hope Biosciences adipose derived Mesenchymal Stem Cells. |
Browse Conditions
| Sequence: | 191805843 | Sequence: | 191805844 | Sequence: | 191805845 | Sequence: | 191805846 | Sequence: | 191805847 | Sequence: | 191805848 | Sequence: | 191805849 | Sequence: | 191805850 | Sequence: | 191805851 | Sequence: | 191805852 | Sequence: | 191805840 | Sequence: | 191805841 | Sequence: | 191805842 |
| Mesh Term | Neuromuscular Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Polyradiculoneuropathy | Mesh Term | Autoimmune Diseases of the Nervous System | Mesh Term | Demyelinating Diseases | Mesh Term | Autoimmune Diseases | Mesh Term | Immune System Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Polyneuropathies | Mesh Term | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Mesh Term | Peripheral Nervous System Diseases |
| Downcase Mesh Term | neuromuscular diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | polyradiculoneuropathy | Downcase Mesh Term | autoimmune diseases of the nervous system | Downcase Mesh Term | demyelinating diseases | Downcase Mesh Term | autoimmune diseases | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | polyneuropathies | Downcase Mesh Term | polyradiculoneuropathy, chronic inflammatory demyelinating | Downcase Mesh Term | peripheral nervous system diseases |
| Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 47931653 | Sequence: | 47931654 |
| Agency Class | OTHER | Agency Class | INDUSTRY |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | Hope Biosciences Stem Cell Research Foundation | Name | Hope Biosciences |
Overall Officials
| Sequence: | 29041316 |
| Role | Principal Investigator |
| Name | Djamchid Lotfi, MD |
| Affiliation | Hope Biosciences Stem Cell Research Foundation |
Eligibilities
| Sequence: | 30521665 |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria Patient diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, with documented medical records. Patient must have banked his stem cells at Hope Biosciences LLC. Exclusion Criteria The patient has any active infection requiring medications. The patient has any suicidal ideation during the screening visit or at any point during the study. |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254082090 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
Intervention Other Names
| Sequence: | 26471256 |
| Intervention Id | 52075719 |
| Name | MSCs |
Responsible Parties
| Sequence: | 28650823 |
| Responsible Party Type | Sponsor |