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| Name | Class |
|---|---|
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First patient group | Experimental | Low dose |
|
| Second patient group | Experimental | High dose |
|
| Third patient group | Experimental | Best dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNDP-001 | Biological | Stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals | Baseline to 15 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline in Quality ON time measured by PD diary | Baseline to 15 months post-transplant | |
| Changes in Dopaminergic Function and Activity in the Brain | Changes in L-DOPA-positron emission tomography (PET) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| General Inquiries | Contact | <need to obtain> | patients@kenaitx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85721 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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IPD sharing plan will be determined later in the development.
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| Syringe Front-Loading Device | Device | Delivers the stem cells |
|
| Baseline to 15 months post-transplant |
| Keck Medical Center of University of Southern California | Recruiting | Los Angeles | California | 90033 | United States |
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
|