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Therapeutic Area:

•    Oncology
•    Rare Genetic Disorders
•    Cardiovascular Diseases
•    Neurological Disorders
•    Metabolic Disorders
•    Immunologic Disorders
•    Ophthalmic (Retina & Optic Nerve) Disorders

Treatment guideline:

G0 or Zero Injection
In the context of autologous cell therapy for neurologic diseases, the Zero Day Injection refers to the systemic infusion of bone marrow-derived samples on the same day as the cell harvesting procedure. This process involves the removal of red blood cells (RBCs) and the activation of mononuclear cells (MNCs) using a specific high-tech material and method to prepare the cells for therapeutic use.

1. Removal of Red Blood Cells (RBCs):
The bone marrow aspirate collected from the patient contains a mixture of cells, including RBCs, white blood cells, platelets, and stem cells. To prepare the sample for infusion, the RBCs need to be separated and removed from the mixture. This is typically done through a process called density gradient centrifugation, where the different cell types are separated based on their density and sedimentation properties.

2. Activation of Mononuclear Cells (MNCs):
After the RBCs are removed, the remaining mononuclear cells (MNCs) in the sample need to be activated to enhance their regenerative potential. Activation of MNCs can be achieved using specific high-tech materials or methods, such as cytokines, growth factors, or specialized culture conditions. This activation process primes the cells to exhibit therapeutic properties and enhance their ability to promote tissue repair and regeneration.

3. Systemic Infusion:
Once the bone marrow sample has been processed to remove RBCs and activate MNCs, it is ready for systemic infusion back into the patient. The activated MNCs, along with other cell populations present in the sample, are delivered systemically through intravenous infusion. This allows the cells to circulate throughout the body and reach target tissues, including the central nervous system, where they can exert their regenerative effects.

The Zero Day Injection procedure aims to harness the regenerative potential of bone marrow-derived cells by preparing them for systemic delivery on the same day as the cell harvesting process. By removing RBCs, activating MNCs, and administering the cells systemically, researchers and clinicians can optimize the therapeutic efficacy of autologous cell therapy for neurologic diseases and potentially enhance patient outcomes.

2nd to Nth Injection
- Explanation: Following the initial G0 injection, additional injections (2nd to Nth) may be administered at scheduled intervals. These booster injections help reinforce the therapy’s effects, ensuring that the engineered cells remain active and effective within the patient’s system. This process may also involve monitoring the patient for any adverse reactions or complications.

Trial Phases:

•    Early Phase (Phase I): Focus on safety and dosing.
•    Intermediate Phase (Phase II): Evaluate efficacy and side effects.
•    Late Phase (Phase III): Confirm effectiveness and monitor adverse reactions in larger groups.