As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
CellTrials.org is the ONLY database in the world that compiles advanced cell therapy clinical trials from ALL national registries, not just ClinicalTrials.gov. From 2017 to 2018, the average monthly fraction of clinical trials outside ClinicalTrials.gov has risen 65%, from 23% to 38%.
The growth of advanced cell therapy from 2017Q1 to 2018Q1 is primarily driven by trials registered outside of ClinicalTrials.gov. Outside trials include registries in China, Japan, India, Iran and Australia.
New database from CellTrials.org holds clinical trials performing advanced cell therapy with isolated MSC, from any source. The number of MSC trials registered each year has increased 50% in the past five years and the fraction of trials using MSC from perinatal sources has increased from 20% to 30%. Automated tools that collect MSC trials from ClinicalTrials.gov by keyword search will only find 70% of the world’s MSC trials and will only have 82% accuracy in the trials retrieved from ClinicalTrials.gov.
Duke University Medical Center has received permission from the FDA to offer cord blood therapy for conditions like autism spectrum disorder and cerebral palsy under an expanded access clinical trial. This expanded access means that children worldwide who have acquired neurologic conditions can have access to cord blood therapy regardless of whether they qualify for a targeted clinical trial. The only restriction is that they must have their own cord blood or a matching sibling's cord blood in storage, most likely in a family cord blood bank.
The number of clinical trials that work with placental cells and tissue exceeds the number that can be found by searching on the keyword "placenta". Dozens of clinical trials use the placenta but do not contain the keyword "placenta". But, out of hundreds of clinical trials that use the placenta, we find that only 4% are conducting advanced cell therapy.
Now that the mid-point of 2017 has passed, we can give a brief update on the growth rate of advanced cell therapy from 2016 to 2017. The number of trials registered worldwide was 582 for all of 2016 and 315 for the first half of 2017, a modest 8% increase in the average number of trials per month.
Our latest featured trial is NCT03015623, which was registered in January 2017 but started recruiting patients in June 2017. In this trial, patients with acute kidney injury have their blood filtered through a device that holds mesenchymal stem/stromal cells from allogeneic bone marrow.
Duke University is the first academic center in the west to register a Phase 1 trial testing MSC infusions as therapy for autism. The MSC product will be isolated from umbilical cord tissue by enzymatic digestion, expanded in culture, and cryopreserved.
Registered in February 2017, this trial is a phase 1/2 study that compares bone marrow MSC versus umbilical cord tissue MSC for the treatment of chronic inflammation due to metabolic syndrome.