Process

The process of developing and translating a novel therapy is complex and expensive.  According to the US FDA, that process often ends in failure because the investigators rely solely on clinical endpoints in early clinical trials versus additional biomarkers of efficacy.  This reliance on clinical endpoints is particularly problematic in the development of cellular therapies.  A failure to observe a clinical response raises the question of whether a sufficient number of cells were delivered to, and/or persisted at the site(s) of action.  Do changes in dose, the route of administration or the addition of co-therapies affect the fate of the cell product?  Conversely, the manifestation of undesired side effects raises the question of whether large numbers of cells were delivered off-target.

Cell Sense is used to develop pharmacokinetic data for cellular therapies.  The process begins with planning preclinical and clinical experiments designed to prove the investigator’s hypotheses regarding the delivery, migration, and persistence of the therapeutic cells in patients.

The framework below provides general guidelines for the use of Cell Sense to develop cell tracking data in a Phase I clinical study; a specific process related to your study may differ.

Celsense welcomes the opportunity to assist customers with solving their challenging in vivo imaging problems. Our research and development staff are experts in cell biology and MRI methods. They have a depth of experience in the practical use of Celsense’s products. Our services include developing cell labeling protocols, validation studies, imaging experimental design, and study management.

The biology laboratory at Celsense is capable of performing most modern cell-based assays, under cGLP-like standards. Celsense partners with leading CROs to conduct preclinical experiments, including in vivo MRI.

Please contact info@celsense.com for more information on our Sponsored Research Services.

01

Study Design

  • What are the questions you’re looking to answer?
  • What will the answers mean?

02

Develop in vitro data set

IND enabling studies

  • Optimize labeling under desired conditions
  • Demonstrate labeled cells will meet product release criteria
  • Optional development of in vivo preclinical data

03

Prepare and Submit IND application

  • Includes the in vitro data set comparisons of labeled and unlabeled cells

04

Enable clinical trial site

  • Optimize MRI scanning parameters
  • Image phantoms

05

Treat Patients

  • Evaluate images
  • Correlate imaging data with outcomes

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Celsense offers products that enable real-time MRI detection of inflammation and cellular therapeutics. The mission of the company is to be the standard for cellular imaging in human health.

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