The cord blood industry came into existence in the early 1990’s with the formation of several leading cord blood banks in the U.S., followed by the formation of cord blood banks across the globe. It has now been almost 40 years since it was first proposed that stem and progenitor cells were present in human cord blood, so the question is, what will the next 40 years hold for the cord blood banking industry?
The last few years have been marked by substantial change, as explored below.
Recent Changes within the Cord Blood Industry
The cord blood industry has five key themes impacting the industry, which include:
1. Diversification of Services
Cord blood banks are rapidly introducing new types of perinatal tissue stem cell storage. These services include the storage of:
- Umbilical cord tissue (Wharton’s Jelly)
- Placental blood and tissue
- And more
Although cord blood storage emerged nearly 30 years ago, cord tissue storage didn’t emerge as a commercial service until 2008, when a Taiwanese company, HealthBanks Biotech Company Ltd., began offering the service – making it the first company worldwide to do so. HealthBaby, a Hong Kong based company subsequently launched the service in 2009, and another Hong Kong based company, Cryolife, added the service in 2009 as well. Within the U.S., Cord Blood Registry (CBR) was the first private company to begin offering cord tissue storage in July of 2010.
Although the service of cord tissue storage is a recent phenomenon, approximately two-thirds of private banks worldwide now offer the service. Within the U.S., the percentage is even higher at three-quarters of private cord blood banks.
For placental banking, LifebankUSA initiated the service in the U.S. when it launched placental blood storage services in 2006 and placental tissue storage services in 2011. In September 2017, Americord Registry became the second U.S. cord blood bank to launch the service of placental tissue banking. Internationally, several dozen cord blood banks now offer placental blood and tissue banking.
Globally, there are also banks like LifeCell International (India’s largest cord blood bank) that offer storage for up to 10 different kinds of stem cells.
2. Pairing with Prenatal / Neonatal / Maternal Health Services
Repeatedly, the cord blood industry has seen companies pair prenatal, neonatal, and maternal health services with cord blood and tissue storage services.
Examples of this trend include:
- Natera, a leader in genetic testing, launched its EverCord Cord Blood & Tissue Banking Service
- ViaCord’s launched its Newborn Genetic Screening
- Human Longevity acquired LifebankUSA (owned by Celgene) to pair its Newborn Genome Sequencing Service with cord blood, cord tissue, and placental banking
- AMAG Pharmaceuticals acquired Cord Blood Registry (CBR) to bolster its portfolio of maternal health products
- Donor Egg Bank, a California Cryobank company offering frozen eggs for use in childbirth, offers free processing of its clients’ newborn cord blood through its sister company, FamilyCord
3. Industry Consolidation
Cord blood industry consolidation is another major theme going on worldwide. Examples of this trend include the largest Canadian bank (Insception) merging with the largest Australian bank (Cell Care Australia Pty Ltd.) and Cryoholdco buying up cord blood banks in Latin America.
Additionally, Sanpower Group has emerged the largest cord blood banking operator in China and SE Asia after buying China Cord Blood Corporation (CCBC) and Shandong Cord Blood Bank. It now controls over 1.1 million cord blood units within its network.
- Human Longevity acquired LifebankUSA from Celgene in January of 2016
- AlphaCord acquired LifeSource Cryobank in November 2015 (its 5th acquisition of smaller banks)
- FamilyCord acquired Southern Cord (April 2016) and the assets of Cord Blood America, Inc. (February 2018)
- Cryosite bolstered CellCare’s dominance within the Australian market by selling cord blood and tissue banking assets to Cell Care Australia in June 2017
- Cordlife Group acquired HealthBaby Hong Kong for US$7 million in cash (S$9.3 million) in January 2018
4. Cord Blood Banks as Integrated Therapeutic Companies
Cord blood banks are investigating means of becoming integrated therapeutic companies. In one example, LifebankUSA recently became an asset of the augmented immunity and longevity company Celularity, Inc., which raised an astounding $250 million in investor financing in February 2015. Americord announced in a press release that it “intends to launch its first therapeutic product offering sometime in 2018.”
Similarly, LifeCell International, India’s largest cord blood bank, is building a facility in Jhajjar, Haryana, to manufacture mesenchymal stem cells (MSCs) and run clinical trials anticipated to be operational by 2021. The trend of integrating cord blood therapeutics appears to be gathering momentum within the industry.
5. Focus on Cord Blood Cell Expansion
The cord blood banking industry is giving a great deal of attention to the pursuit of cord blood expansion, because the limited cell dose present within an unmanipulated cord blood unit restricts the efficacy of hematopoietic stem cell transplantation (HSCT) in adult patients. Fortunately, there has been substantial progress in this area. Key strategies being explored for this purpose include Nicotinamide-mediated (NAM) expansion, Notch ligand, UM171, SR-1, and others.
Currently, Gamida Cell Ltd, NohlaTherapeutics, and Excellthera have cord blood expansion products in Phase II clinical trials, while Magenta Therapeutics has a Phase I trial underway. The industry has never before achieved this level of validation for cord blood expansion technologies, making it an exciting time for the industry.
Key strategies being explored for cord blood expansion include:
- NiCord – Gamida Cell (Jerusalem, Israel) is exploring cord blood stem cell expansion with NiCord, a small molecule mediated approach that works via epigenetic regulation induced by nicotinamide.
(Clinical Trial NCT01816230 – “Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM“)
- Notch-1 Ligand – Nohla Therapeutics (Seattle, Washington) is exploring cord blood stem cell expansion using the Notch-1 ligand.
(Clinical Trial NCT01690520 – “Donor Umbilical Cord Blood Transplant With or Without Ex-vivo Expanded Cord Blood Progenitor Cells in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, or Myelodysplastic Syndromes“)
- StemRegenin-1 (SR1) – SR1 is an aryl hydrocarbon receptor antagonist that expands CD34+ cells. Research in this area has been sponsored by Novartis Pharmaceuticals and led by Dr. John Wagner of the University of Minnesota Medical School.
(Clinical Trial NCT01474681 – “Safety and Tolerability of HSC835 in Patients With Hematological Malignancies“)
- UM171 – First identified by Canadian researchers at the University of Montreal, UM171 is a pyrimido-[4,5-b]-indole derivative that improves self-renewal of human hematopoietic stem cells (HSCs).
(Clinical Trial NCT02668315 – Expanded Cord Blood in Patients in Need of an Allogeneic Stem Cell Transplant)
- Enforced Fucosylation – Ex vivo cord blood manipulation via enforced fucosylation appears to accelerates neutrophil and platelet engraftment after transplantation.
(Clinical Trial NCT01471067 – “Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies“
- Dimethyl Prostaglandin E2 – This approach by Fate Therapeutics regulates the Wnt pathway in hematopoietic stem and progenitor cells (HSPCs), which has led the company to explore it for ex vivo expansion of umbilical cord blood stem cells.
(Clinical Trial NCT01527838 – “Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit“)
- MGTA-456 – MGTA-456 is a clinical-stage program in-licensed by Magenta from Novartis
, formerly HSC835. According to Magenta: “Early results published in Science demonstrated the ability of MGTA-456 to significantly increase the number of umbilical cord blood stem cells. Clinical results reported in Cell Stem Cell demonstrated that this approach yielded an increased expansion of stem cells.”
- Small Molecule Approach (Plasticell) – Plasticell has developed a small-molecule driven, GMP-compliant method of expanding hematopoietic stem cells from cord blood, bone marrow and peripheral blood. The therapy has been part-funded by multiple programme grants from Innovate UK and developed in collaboration with NHS Blood and Transplant, the University of Oxford and the Cell and Gene Therapy Catapult.