The Medical Technology Enterprise Consortium announced a Request for Project Information focused on Cellular Therapy for the Treatment of Hemorrhagic Shock in Severely Injured Patients.
Submit your project information papers to MTEC by 11:59 p.m. on Thursday, March 9, 2017 to firstname.lastname@example.org!
Project information papers will be used to judge the approach, maturity and past history that supports clinical study engagement, readiness for clinical study, the capacity of the proposer to accomplish the clinical study and the projected financial costs of moving the product forward.
MTEC members and non-members may submit project information papers, but note that MTEC membership is required to submit a full proposal in response to a future MTEC request for project proposals for Cellular Therapy for the Treatment of Hemorrhagic Shock.
The MTEC is looking for project information for cell therapies that can be used to treat inflammatory complications that arise after traumatic injury (but not cell therapies that can be used to achieve hemostasis).
The request is focused on the following major tasks:
- Produce clinical grade cellular therapy agent in sufficient quantity to conduct a clinical assessment in a trauma patient population. Assessment needs to account for relevant regulations for prototypes to be administered to humans and ensure documentation of appropriate quality and process controls. The proposer will come forth with the appropriate protocol and surgical procedure that will serve as the basis for evaluation and supports labeling as a hemorrhagic shock therapy.
- Develop a clinical study to assess mechanistic and outcome based patient responses to administration of cellular therapies with appropriate controls for administration of cellular therapy (placebo control; potential confounding treatments such as inclusion/exclusion, hemostasis and blood transfusion; and outcomes assessment, blinding as to treatment). Relevant outcomes may include inflammation and inflammatory complications, organ function/injury scores and mortality. In addition, all safety data and indications need to be identified for capture and review.
- Document sufficient patient population (number, severity, availability in the acute post injury phase and ability to conduct exemption from informed consent) to ensure assessment of prototype cellular therapy is conducted in a timely manner.
- Consider capacity for future assessment of cellular therapies from a variety of sources (such as industry, academic labs and international partners) in a well-described clinical population as a reimbursable service.
Proposed products need to be ready to enter the clinical stage in a short window and have all regulatory requirements for IND prepared for submission as a minimum as they’re looking to forward at least one cell therapy prototype to a Phase II clinical trial.
If manufacturing of your product is required, that must be stated and the cost identified accordingly. Manufacturing is not the focus of the effort, but the product must be made available under GMP standards to move forward.