What is a Clinical Trial?
Clinical trials study potential new treatments in healthy volunteers or people with a specific illness or condition. They are an indispensable tool to determine the safety and efficacy of new drug candidates before they can be used to treat illness.
The first clinical trial in the United States and Canada to study pluripotent stem cell-derived dopaminergic neurons in people living with Parkinson’s disease is currently underway. This Phase 1 study of DA01 is enrolling patients with advanced Parkinson’s Disease who meet the following criteria:
- Aged: 60-76 in the U.S.; 50-76 in Canada
- Diagnosed with Parkinson’s disease between 5 and 15 years ago
- Their regular Parkinson’s medications are no longer fully effective or have caused side-effects
- Have not had a surgical treatment for their Parkinson’s disease (i.e., Deep Brain Stimulation)
The study objectives are to assess the safety and tolerability. Participants in the trial will receive dopamine-producing neural cells through surgical implantation into the putamen, the area of the brain that regulates movement.
DA01 is an experimental product candidate and has not been approved by any regulatory agencies. To learn more about the clinical trial, visit clinicaltrials.gov.
Report An Adverse Event
Humans vary in their biological reactions to medicinal products. This is why not all adverse events (side effects) associated with the use of medicinal products can be detected during clinical development. An adverse event is any undesirable experience associated with the use of a medical product in a patient. Capturing as many of these adverse events, however rare they may be in absolute terms, is of paramount importance for continued patient and drug safety. If you believe you have suffered an adverse event associated with the use of one of BlueRock’s product candidates, please reach out via email to AEreporting@bluerocktx.com.
Expanded Access Policy
An expanded access program (also known as EAP) and sometimes called “compassionate use,” is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational drug for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. These investigational drugs have not yet been approved or cleared by regulatory bodies like the FDA, and these products have not yet been found to be safe and effective for their specific use.
We understand that some patients may wish to access our investigational drugs that have not yet been approved. At this stage of drug development and trials, we do not have enough clinical product or evidence of clinical safety and efficacy of our investigational drugs to support expanded access. Therefore, BlueRock Therapeutics does not currently offer an expanded access program at this time. The most appropriate way for patients to access our investigational drug is by participating in our clinical trials, and we encourage you to speak with your doctor about whether you would qualify for this trial. Information regarding ongoing clinical trials can be accessed at www.clinicaltrials.gov. (Identifier: NCT0480273)
In accordance with the 21st Century Cures Act, this policy may be revised at any time. If you have additional questions about BlueRock’s expanded access policy, please speak to your physician, or contact firstname.lastname@example.org. We will make our best effort to respond within 5 days.
This page contains information on clinical trials sponsored by BlueRock Therapeutics, is provided for patients and healthcare professionals to increase the transparency of BlueRock’s clinical research, is not intended to replace the advice of a healthcare professional, and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare professionals should always refer to the specific labeling information approved for the patient’s country or region. The data on the website should not be considered as prescribing advice.