5 FDA-Approved Cord Blood Treatments You Didn’t Know Existed

Cord blood is a powerful resource for treating serious health conditions. The FDA has approved five key treatments using cord blood, which are used in stem cell transplants to rebuild blood and immune systems. These therapies address over 80 conditions, such as leukemia, lymphoma, anemias, and inherited disorders. Here's a quick look at these treatments:

• ALLOCORD: Treats blood cancers, immune disorders, and inherited metabolic diseases.
• CLEVECORD: Focuses on blood cancers, immunodeficiencies, and bone marrow vs. cord blood failure.
• Ducord: Addresses leukemia, lymphoma, and genetic blood disorders.
• HEMACORD: The first FDA-approved cord blood therapy, used for blood and immune disorders.
• REGENECYTE: Targets blood cancers and immune system deficiencies, with ongoing studies for new applications.

Cord blood banking provides families with access to these treatments, acting as a safety net for future health needs. These therapies are rigorously tested, ensuring safety and efficacy. If you're considering banking cord blood, it's vital to use a facility that meets FDA standards for quality and storage.

1. ALLOCORD (HPC, Cord Blood) by SSM Cardinal Glennon Children's Medical Center

ALLOCORD is one of the few cord blood products approved by the FDA, showcasing the advances possible in regenerative medicine.

FDA Approval Status

ALLOCORD has earned FDA approval as a licensed cellular and gene therapy product. It is among the select cord blood therapies recognized for use in the United States. As of December 9, 2025, it remains an approved treatment, meeting the rigorous standards set by the FDA.

Medical Applications in Regenerative Medicine

With its FDA approval, ALLOCORD plays a key role in allogeneic stem cell transplantation. This procedure uses donor cord blood to rebuild a patient's blood and immune systems. The stem cells in ALLOCORD differentiate to restore these vital functions, which is especially critical for patients whose systems have been compromised by chemotherapy, radiation, or underlying diseases. It supports both blood and immune system recovery, making it a cornerstone for treating a wide range of related disorders.

Specific Health Conditions Treated

ALLOCORD is designed to address conditions that affect the blood-forming system. These include inherited or acquired disorders, as well as those resulting from intensive treatments like chemotherapy. Conditions treated with ALLOCORD include:

• Various forms of leukemia
• Hodgkin's and Non-Hodgkin's lymphoma
• Blood disorders such as different types of anemia and Thalassemia
• Inherited metabolic disorders like Hurler Syndrome, Krabbe Disease, and Sanfilippo Syndrome
• Immune system disorders such as Severe Combined Immunodeficiency and Wiskott-Aldrich Syndrome

This broad range of applications underscores its importance in regenerative medicine.

Availability and Accessibility in the United States

ALLOCORD is accessible across the country through public transplant networks and national registries. Healthcare providers can request matched cord blood units, ensuring families have access to a safe and regulated source of stem cells for treating life-threatening rare diseases.

2. CLEVECORD (HPC Cord Blood) by Cleveland Cord Blood Center

CLEVECORD is an FDA-approved cord blood therapy produced by the Cleveland Cord Blood Center, based in Cleveland, Ohio.

FDA Approval Status

CLEVECORD received its initial FDA approval on September 1, 2016, officially classifying it as a licensed biological product. As of December 9, 2025, it remains approved, standing out as one of the few cord blood products to achieve FDA licensure. This recognition ensures its use in regenerative treatments is both regulated and effective.

Medical Applications in Regenerative Medicine

Similar to ALLOCORD, CLEVECORD represents a major step in cord blood treatments aimed at restoring essential blood and immune functions. As an allogeneic therapy, it uses donor-derived cells for transplantation. Once administered, the hematopoietic stem cells settle in the bone marrow, where they develop and eventually enter the bloodstream. This process helps patients recover blood counts and immune function. Clinical results show 96% neutrophil recovery and 92% platelet recovery by Days 42 and 100, respectively, with median recovery times of 18 days for neutrophils and 41 days for platelets.

Specific Health Conditions Treated

CLEVECORD is used to treat a range of conditions affecting the blood-forming system, whether inherited, acquired, or related to prior treatments. It is effective against hematologic cancers such as leukemia and lymphoma, as well as inherited metabolic disorders, where the transplanted cells can produce enzymes that the patient’s body is missing. Additionally, it treats primary immunodeficiencies and bone marrow failure syndromes. Each unit contains at least 500 million total nucleated cells and 1.25 million viable CD34+ cells at cryopreservation, ensuring sufficient potency for treatment.

Availability and Accessibility in the United States

CLEVECORD is available at authorized transplant centers nationwide, following its proven clinical success. It is administered intravenously by physicians specializing in hematopoietic progenitor cell transplantation. To ensure compatibility, healthcare providers recommend HLA matching of at least 4 out of 6 HLA-A, HLA-B, and HLA-DRB1 alleles before selecting a cord blood unit. The product is stored under strict cryogenic conditions to preserve cell viability.

3. Ducord (HPC Cord Blood) by Duke University School of Medicine

Ducord is a cord blood therapy approved by the FDA and produced by the Carolinas Cord Blood Bank (CCBB) at Duke University School of Medicine in Durham, North Carolina.

FDA Approval Status

Ducord's FDA approval highlights its early role in regenerative medicine. Approved on October 8, 2012, it was one of the first cord blood therapies in the U.S. to achieve this milestone. Dr. Robert Califf, then Vice Chancellor for Clinical Research at Duke, emphasized the importance of this approval:

"FDA approval is a major statement about the quality of the product and the methods used to produce it."

The approval process required rigorous documentation of collection, testing, processing, and storage protocols.

Medical Applications in Regenerative Medicine

Ducord contains hematopoietic progenitor cells, which are capable of self-renewing and transforming into specialized blood cells. Once transplanted, these cells travel to the bone marrow, where they help restore blood and immune system functions. This process is crucial for patients whose blood-forming systems have been compromised. Dr. Joanne Kurtzberg, Medical Director and Founder of the CCBB, noted:

"Licensure enables the CCBB to continue to provide cord blood units to patients in need of a donor for unrelated transplantation... it enables the CCBB to offer premium cord blood units for emerging cellular therapies." This progress is part of a broader landscape of stem cell treatments and clinical trials currently expanding the reach of regenerative medicine.

This ability to regenerate blood and immune systems makes Ducord essential in treating various conditions.

Specific Health Conditions Treated

Ducord is used to treat a range of hematopoietic system disorders, whether they are inherited, acquired, or caused by myeloablative treatments. These include leukemia, lymphoma, genetic blood disorders, inherited metabolic conditions, and immune system deficiencies. It is specifically designed for procedures requiring donor cord blood transplantation to restore hematopoietic and immune functions.

Availability and Accessibility in the United States

Ducord's proven clinical effectiveness has made it widely available across the U.S. All units are listed on the "Be the Match" registry, part of the National Bone Marrow and Donor Program, ensuring accessibility to transplant centers nationwide. Since its founding in 1998, the CCBB has banked over 25,000 cord blood units from racially and ethnically diverse donors. These units are collected from seven hospitals in North Carolina and Brigham and Women's Hospital in Boston. Healthcare providers can use the registry to find matching units for patients in need of transplantation.

4. HEMACORD (HPC, Cord Blood) by New York Blood Center

HEMACORD holds a landmark position in the field of cord blood therapies as the first FDA-licensed stem cell product in the world. Developed by the New York Blood Center, this therapy was approved on November 10, 2011, under the National Cord Blood Program (NCBP). Its approval marked a significant advancement in the availability of regulated cord blood treatments.

FDA Approval Status

The FDA's decision to approve HEMACORD was backed by clinical evidence from over 4,000 cord blood grafts, showcasing its consistent effectiveness across diverse patient groups. Dr. Christopher D. Hillyer, President and CEO of the New York Blood Center, expressed the importance of this milestone:

"We are thrilled to be the first public cord blood bank with an FDA-licensed product for transplantation."

This approval required strict compliance with FDA guidelines for collection, processing, and distribution, ensuring high-quality standards for every step of the therapy.

Medical Applications in Regenerative Medicine

HEMACORD plays a critical role in restoring blood and immune system functions for patients with compromised systems. It is specifically designed for unrelated donor transplants, where matching units from public cord blood banks can provide life-saving solutions. The therapy's production adheres to rigorous standards to guarantee the consistency, safety, and effectiveness of each cord blood unit.

Specific Health Conditions Treated

HEMACORD is used to treat a variety of blood and immune-related disorders, including:

• Leukemia and lymphoma
• Primary immunodeficiency diseases
• Bone marrow failure syndromes
• Inherited conditions like beta-thalassemia

It is approved for use in both children and adults facing these serious health challenges.

Availability and Accessibility in the United States

To meet the demand for optimal HLA matching, thousands of HEMACORD units are available nationwide. Transplant centers can access these units through platforms like the NCBP's WebSearch system, Bone Marrow Donors Worldwide (BMDW), or the National Marrow Donor Program. Families interested in exploring cord blood options can contact the New York Blood Center’s National Cord Blood Program at 1-866-767-NCBP (1-866-767-6227). Additionally, most U.S. health insurance providers cover stem cell transplants when deemed a standard treatment for the patient’s condition.

5. REGENECYTE (HPC, Cord Blood) by StemCyte, Inc.

REGENECYTE builds on the success of earlier FDA-approved cord blood treatments, offering new possibilities in regenerative therapies. It’s the first commercially licensed cord blood stem cell therapy, with StemCyte receiving Biologics License Application (BLA) approval on November 22, 2024. This milestone solidifies StemCyte’s role as a leader in the field. Their cGMP-certified facility in Baldwin Park, California, ensures the production of high-quality units.

FDA Approval Status

The FDA has approved REGENECYTE for use in unrelated donor transplants. Dr. Tong Young Lee, CEO of StemCyte, highlighted the company’s extensive resources and expertise:

"With one of the largest inventories of cord blood stem cells worldwide, StemCyte is uniquely positioned to supply, manufacture, and develop advanced cell therapy products." – Dr. Tong Young Lee, CEO, StemCyte

Achieving FDA approval required strict compliance with U.S. regulations and international standards from organizations such as AABB and FACT.

Medical Applications in Regenerative Medicine

REGENECYTE is designed to restore blood and immune system functions in patients needing hematopoietic and immunologic reconstitution. While it continues to address critical blood and immune deficiencies, StemCyte is also expanding its focus. Phase II trials are currently investigating its potential in treating long COVID and acute stroke, with additional studies exploring applications for chronic fatigue syndrome and age-related conditions.

Specific Health Conditions Treated

This therapy targets disorders of the hematopoietic system, whether inherited, acquired, or resulting from intensive treatments like high-dose chemotherapy. Conditions include various blood cancers, primary immunodeficiency diseases, and bone marrow failure syndromes. However, it’s important to note that the FDA has not approved cord blood therapies for conditions such as autism, Alzheimer's, or orthopedic issues.

Availability and Accessibility in the United States

REGENECYTE units are available through StemCyte’s extensive public cord blood inventory. Patients eligible for unrelated donor transplants can access these units via their transplant centers, which work directly with StemCyte’s California facility. The company’s compliance with multiple regulatory standards ensures reliable access for patients across the U.S.

How Americord Registry Preserves Cord Blood

Ensuring the quality of cord blood is crucial for the effectiveness of FDA-approved treatments, and Americord Registry has developed methods to maintain its viability over time.

At the heart of their approach is CryoMaxx™ Processing, a proprietary method designed to optimize the potential of cord blood stem cells. Unlike automated systems, Americord uses manual processing to maintain a higher level of quality control.

Americord also employs a 5-compartment storage bag that allows stem cells from a single collection to be divided into five portions. This design makes it possible to access multiple treatments from one collection, offering flexibility for future use.

Once processed, the stem cells are stored at -196°C (about -320°F) in a state-of-the-art facility located in Somerset, New Jersey. This FDA-registered, AABB-accredited facility includes pharmaceutical-grade clean rooms for processing and features round-the-clock temperature monitoring with automatic alerts to prevent any issues. These meticulous measures ensure the highest level of quality assurance.

Americord stands behind its methods with a $110,000 Cord Blood Quality Guarantee, which covers the cost of an alternative stem cell source if the stored cells fail to engraft. To date, the company has achieved a 100% success rate for the 14 cord blood units it has released for autologous transplants, reflecting the reliability of its processes.

For families considering cord blood banking, plans begin at $145 per month over 24 months with 0% interest. Their 4-in-1 collection kit allows parents to preserve cord blood, cord tissue, placental tissue, and exosomes all at once.

Conclusion

The five FDA-approved cord blood treatments discussed - ALLOCORD, CLEVECORD, Ducord, HEMACORD, and REGENECYTE - highlight the progress cord blood banking has made as a life-saving option. These treatments adhere to strict FDA standards for safety, purity, and potency and are used in hematopoietic stem cell transplants to treat conditions like blood cancers, genetic disorders, and immune deficiencies.

In addition, the FDA's recent approval of Omisirge in December 2025 marks a significant step forward. Omisirge, designed for severe aplastic anemia, boasts a median neutrophil recovery time of just 11 days. Dr. Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director of the FDA's Center for Biologics Evaluation and Research, remarked:

"This approval is revolutionary in the therapeutic landscape and fundamentally changes how we approach treatment for SAA, where earlier treatment has potential to alter one's life course."

These advancements emphasize the practical value of cord blood banking. With FDA approval for treatments addressing over 80 conditions, cord blood banking becomes a proactive way to support family health. Its compatibility within families is a key advantage, especially when considering that 1 in 3 people may benefit from regenerative medicine or stem cell transplants during their lifetime. This shifts the conversation from "what if" to "how prepared are we?"

To maximize the benefits, it's essential to ensure high-quality collection and storage. Look for facilities that meet FDA standards for processing and storage. For example, Americord Registry operates an FDA-registered, AABB-accredited facility with advanced techniques to preserve cell viability, supported by a $110,000 engraftment guarantee. Since cord blood can only be collected at birth, planning the collection process ahead of time is crucial.

FAQs

Is my baby’s cord blood likely to be used by our family?

The likelihood of your baby’s cord blood being used largely depends on your family’s specific medical needs. Cord blood is utilized in numerous FDA-approved treatments for a range of conditions, and family members often qualify as donors or recipients. Banking cord blood offers a resource that could be tapped for potential health needs in the future.

What’s the difference between public donation and private banking?

Public donation and private banking of cord blood cater to distinct needs. With public donation, cord blood is made accessible to anyone who might need it, and there’s no cost to the donor for storage. Private banking, however, requires a fee to store the cord blood exclusively for your family’s potential use. The main distinction lies in who benefits: public donation supports others, while private banking is a safeguard for your own family.

What makes cord blood “high quality” for a future transplant?

High-quality cord blood refers to blood with a rich concentration of viable stem cells that are carefully preserved and meet strict FDA standards for both safety and effectiveness. These standards ensure the stem cells remain capable of successful engraftment, making them reliable for regenerative treatments when required.