Efficient and robust generation of functional hematopoietic cells from human pluripotent stem cells in albumin-free conditions.

Byung Woo Kim, Linyi Zhang, Mo Liu, Supreet Khanal, Ye Eun Jeong, Ge Zheng, Nirjal Bhattarai, Zhaohui Ye

Abstract read

In one paragraph

Article in Stem cells translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Byung Woo KimGene Transfer and Immunogenicity Branch, Division of Gene Therapy 2, Office of Gene Therapy CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Linyi ZhangGene Transfer and Immunogenicity Branch, Division of Gene Therapy 2, Office of Gene Therapy CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Mo LiuGene Transfer and Immunogenicity Branch, Division of Gene Therapy 2, Office of Gene Therapy CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Supreet KhanalTumor Vaccine and Biotechnology Branch, Division of Cell Therapy 2, Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Ye Eun JeongDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Ge ZhengGene Transfer and Immunogenicity Branch, Division of Gene Therapy 2, Office of Gene Therapy CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Nirjal BhattaraiTumor Vaccine and Biotechnology Branch, Division of Cell Therapy 2, Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Zhaohui YeGene Transfer and Immunogenicity Branch, Division of Gene Therapy 2, Office of Gene Therapy CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.ORCID 0000-0001-5272-9168

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Generation of human hematopoietic stem and progenitor cells (HSPCs) from pluripotent stem cells (PSCs) holds significant promise in disease modeling, drug screening, and the development of cell and gene therapies for various hematologic and nonhematologic disorders. However, efficient and consistent derivation of functional HSPCs remains a major challenge hindering their practical use in biomedical research and applications. One of the contributing factors is the use of human serum albumin (HSA), which has been widely regarded as essential for supporting ex vivo maintenance, expansion, and differentiation of human stem cells and their derivatives. The lot-to-lot variation of this critical reagent can contribute to inconsistent laboratory results and high manufacturing costs. In this study, we address the manufacturing and regulatory challenges associated with using HSA in HSPC differentiation and propose an approach using a caprolactam-based polymer as an alternative. Our differentiation method demonstrates robust HSPC generation across various embryonic and induced PSC lines and culture conditions, highlighting its adaptability and reliability. Importantly, PSC-derived HSPCs exhibit functional versatility in differentiation capacity into myeloid and lymphoid lineages, as validated through colony-forming assays as well as directed red blood cell and NK cell differentiations. These findings suggest that HSA is dispensable in HSPC differentiation and replacing it with synthetic polymers has the potential to mitigate lot-to-lot reagent variation, improve HSPC production consistency, lower manufacturing costs, and expedite clinical applications.

Indexed as

Cell Culture TechniquesCell DifferentiationHematopoietic Stem CellsPluripotent Stem CellsSerum Albumin, HumanHumansSerum Albumin, Humanalbumin-free differentiationcell and gene therapiesinduced pluripotent stem cells (iPSCs)regenerative medicinestem/progenitor cells

Identifiers

PMID42044971

DOI10.1093/stcltm/szag020

PMCPMC13120835

What OpenQuestion holds

Textmetadata

Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.