ClinImmune & CariCord: A Public/Private Cord Blood Partnership
ClinImmune, led by Brian Freed, PhD, has teamed up with CariCord, led by Calvin Cole. Launched in 2014, this partnership recognizes the growing number of evolving medical applications for both publicly donated and privately stored cord blood stem cells. Parents now have one cord blood bank that both accepts public donations, as well as provides family storage, and develops regenerative medicine therapies, all within a highly accredited and FDA licensed facility.
ClinImmune Labs is an academic-based biotechnology company that operates the public cord blood bank at the University Of Colorado School Of Medicine. Its location on the school's Anschutz Medical Campus in Aurora puts ClinImmune in close proximity to two hospitals performing stem cell transplants (University of Colorado Health and Children's Hospital Colorado).
ClinImmune is also a national provider of cell analysis such as flow cytometry and immunology testing such as solid organ and stem cell pre- and post-transplantation HLA typing for both research and clinical applications. It holds accreditations from the American Society for Histocompatibility and Immunogenetics (ASHI), the College of American Pathologists (CAP), the United Network for Organ Sharing (UNOS), the American Association of Blood Banks (AABB), and the Foundation for the Accreditation of Cellular Therapy (FACT).
ClinImmune was among the first cord blood banks to recognize that size matters in stem cell transplants: transplant physicians mainly want units with large numbers of stem cells. ClinImmune has achieved financial stability by adopting a high storage threshold in their pubic bank. Jonathan Gutman, MD, transplant oncologist at University of Colorado Health and co-medical director of the cord blood bank, says that his program uses cord blood in 60% of their transplant cases. Cumulative over the past two decades, ClinImmune has stored more than 8,500 donated cord blood units at its public bank, leading to more than 725 transplants at 150 different locations around the world.
Under the leadership of Brian Freed, PHD, ClinImmune was the second of only five public cord blood banks to attain a coveted Biologics License Applications (BLA license) from the FDA, a status which certifies that their cell therapy products have met the same level of quality and reproducibility as the preparation of pharmaceutical drugs. This FDA standard was to become legally binding on all US public cord blood banks in 2012, but as yet only five banks have met this requirement.
While some public cord blood banks have argued that the BLA license is too costly and ill-suited to the nature of stem cell transplants, ClinImmune believes that FDA licensure has benefited their donation program in numerous ways: participating hospitals no longer have to manage oversight of donation sites, informed consent is kept simple, all transfers of public cord blood units must have temperature monitoring, pre-storage family health screening is so thorough that there is no need for additional tests before release for transplant, cord blood unit labeling and purity testing are standardized, post thaw quality control is also standardized, and there is complete documentation and validation of all steps and components. Since 2012, ClinImmune has stored 650 cord blood units under its license and released 17, a respectable release rate of 2.6%.
CariCord is the family banking side of ClinImmune, under the leadership of Calvin Cole. Family storage can provide cord blood for sibling transplants, which outperform both unrelated cord blood and bone marrow transplants for long-term survival. Ongoing clinical research is taking place on the treatment of neurologic disorders such as encephalopathy, cerebral palsy, and autism with stem cells from the baby's umbilical cord that were reserved for the family. Finally, family storage can provide raw material for other future regenerative medicine applications.
Global medical director of CariCord, pediatric neurosurgeon Ratan Bhardwaj, MD PhD, notes that CariCord is an "evolutionary model in biological banking" because they are the first private biobank that is teamed up with an FDA licensed public biobank. Describing the collaboration between ClinImmune and CariCord, Bhardwaj coined the phrase:
"Curing Today, Innovating for Tomorrow"
Going forward, ClinImmune and CariCord are moving into a new 112,000 square foot bioengineering facility on the Anschutz Medical Campus of the University of Colorado. The new lab space houses four large cGMP class clean rooms that will enable them to develop cell therapy products that meet pharmaceutical standards.
One of the first cell therapies planned from the new facility is a partnership between the University of Colorado School of Medicine, CariCord, and CellResearch Corp. out of Singapore that will use stem cells harvested from the lining of the umbilical cord to heal diabetic wounds.