Cellphire Therapeutics is committed to developing a new generation of platelet-based therapeutics that more rapidly and effectively treat bleeding, helping to improve and save lives.
Medical progress can only be made through the efforts of our research partners and, especially, the contribution of patients who volunteer to participate in clinical trials.
One of the biggest challenges in clinical trials is recruiting volunteers. Often, the challenge lies in the ability to educate patients. Understanding the potential benefits and risks of participating in a clinical trial can be overwhelming. As a healthcare provider, you can help patients navigate the pros and cons and the questions they may have about clinical trials. With your help, patients can better decide what is the best course for their individual situation.
Cellphire is committed to developing and obtaining regulatory approvals for next generation therapies to improve and save the lives of patients.
All investigational therapies or drugs must go through clinical trials and be approved by a regulatory body such as the U.S. Food and Drug Administration. In most cases, the only way patients can access investigational new drugs is to participate in clinical trials.
However, we understand there may be situations where seriously ill patients may not be eligible or able to participate in a clinical trial. Expanded Access Programs may provide investigational therapies to a limited group of people who are not eligible or able to participate in a clinical trial—but who have a serious or life-threatening disease for which their physician has determined there are no appropriate treatment options.
Cellphire has developed an Individual Patient Expanded Access Policy for Thrombosomes to address the needs of individual patients who may not have access to clinical trials.
Clinical trials are a critical step in the development process of a new therapeutic like Cellphire’s Thrombosomes®. Before you decide whether to participate in a clinical trial, it is important to have as much information as possible.
A clinical trial involves research using human volunteers (also called participants) that is intended to add to medical knowledge. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.
There are many reasons people volunteer for clinical trials. Healthy volunteers may hope to contribute to advancing science. Patients with an illness or disease participate with the hope the investigational treatment may benefit their condition or treatment outcome. While there are no guarantees that the investigational treatment will benefit you, each person who participates in a clinical trial contributes to scientific progress. Your participation helps researchers advance therapies that have the potential to improve and save lives.
Before you decide whether to participate in a clinical trial, it is important to have as much information as possible. Please visit our Frequently Asked Questions for additional information that you may find helpful.
Phase I Clinical Trial: A Phase I, Multi-Center, Open-Label, Dose Escalation Study of Thrombosomes® in Bleeding Thrombocytopenic Patients in Three Cohorts
This study evaluated in a dose-escalation manner, the safety, and preliminary impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in thrombocytopenic patients.
Exploratory Phase I Trial: Safety Evaluation of an Autologous Lyophilized Platelet-derived Hemostatic Product in Healthy Adults
This “first-in-human” exploratory Investigational New Drug (IND), single-center study assessed the safety, toxicity, hematology, and immunogenicity of sub-therapeutic “microdoses” of autologous Thrombosomes in healthy human subjects.