Stem Cell Drug Compliance Services | MSC One-Stop Comprehensive Solution
Release Date:
2025-01-09 14:47
Background Introduction
On January 2, 2025, the National Medical Products Administration granted conditional approval through the priority review and approval process. China’s first stem cell therapeutic drug, Aimimaituosai Injection Approved for marketing for the treatment of Acute graft-versus-host disease with predominant gastrointestinal involvement in patients aged 14 years and older who have failed corticosteroid therapy (aGVHD). Emicizumab injection is China’s first approved mesenchymal stem cell (MSC) therapeutic product, indicated for acute graft-versus-host disease (aGVHD) refractory to corticosteroid therapy. To date, approximately 10 mesenchymal stem cell therapies have been approved globally, with varying cell sources and indications. The past year is destined to be a landmark chapter in the history of stem cell therapy in China, as the gears of destiny begin to turn.
Stem cells are a class of cells with multipotent differentiation capacity that can self-renew in an undifferentiated state. Based on their functions, stem cells can be classified into hematopoietic stem cells, mesenchymal stem cells, and others. Mesenchymal stem cells (MSCs) are a population of cells with self-renewal and multi-lineage differentiation potential, widely distributed throughout various tissues and organs in the human body, including bone marrow, umbilical cord, umbilical cord blood, and adipose tissue; among these sources, bone marrow-derived MSCs are the most commonly used. However, with aging, the number of bone-marrow–derived mesenchymal stem cells declines markedly, and their proliferative and differentiation capacities deteriorate substantially; the preparation process is difficult to quality-control; allogeneic transplantation may elicit immune responses; and the harvesting procedure itself can cause harm to the patient—even in healthy donors, excessive bone-marrow aspiration is not feasible. Consequently, identifying alternative sources of mesenchymal stem cells that are independent of bone marrow has become a critical issue.
Umbilical cord mesenchymal stem cells possess numerous advantageous characteristics, including robust differentiation potential, vigorous proliferative capacity, low immunogenicity, convenient sourcing, absence of ethical and moral concerns, and ease of large-scale industrial production, making them the pluripotent stem cells with the greatest clinical application prospects.
Hycells is an innovative biotechnology company specializing in the provision of primary immune cells, offering customers a one-stop, comprehensive MSC solution. Compliant collection services are available, providing ethically compliant mesenchymal stem cells. Leveraging our proprietary cell bank and culture media R&D technology service platform, we have developed an serum-free MSC expansion kit (Catalog No.: MSC330-500mL ), this is a A high-quality, complete culture medium specifically designed for the primary isolation and serial passaging of human mesenchymal stem cells under serum-free, xeno-free conditions. The MSC serum-free expansion kit supports primary isolation of MSCs using methods such as explant culture and enzymatic digestion, enables long-term, multi-passaging culture of MSCs, and effectively maintains cell characteristics while preserving balanced lineage differentiation potential (e.g., the ability to differentiate into osteoblasts, chondrocytes, and adipocytes).
Compliant umbilical cord sample collection services:
Umbilical Cord Tissue Acquisition Procedure
1) A comprehensive quality management system, compliant data collection services, adherence to ethical standards, and traceable samples. The documentation includes, but is not limited to, the ethics approval document, the donor’s informed consent form (signed), the health questionnaire, the initial and confirmatory testing reports for human-derived viruses in the donor, the screening information forms for the mother and newborn, the umbilical cord collection information form, the sample handover form, the business license of the transportation agency, the temperature-control records for transport, and other relevant records, all of which comply with IND submission requirements.
2) Donor criteria:
Donors are generally aged 20 to 49, with a gestational age of 37. +0 To 41 +6 Week;
Prior to sample collection, a health questionnaire shall be administered, which must include, but is not limited to, the following information: name, age, family history of genetic diseases, past medical history, travel history to areas with high risk of infectious diseases, absence of malignant tumors, gestational hyperglycemia/diabetes/hypertension, and history of pathogen infection.
Human viral agent testing: includes HBV, HCV, TP, CMV, EBV, HTLV-1/2, HIV-1/2 (the basic seven-item viral screening panel), HAV, human herpesvirus-6/7/8, HPV, human parvovirus B19, and human polyomavirus, among others;
Collect information on the newborn, including gestational age, birth weight, amniotic fluid contamination, mode of delivery, presence of meconium-stained amniotic fluid, presence of congenital anomalies, and the newborn’s Apgar scores, among other parameters.
3) Umbilical cord collection and transportation: Record the length of the collected umbilical cord, store it in preservation solution, and ensure cold-chain transport at 2–8°C to arrive within 72 hours, thereby guaranteeing service quality.
MSC Seed Cell Banking Service:
hUC-MSC Bank Construction Process
hUC-MSC Quality Testing Procedure
1) Cell morphology : The cells are long, spindle-shaped fibroblast-like, with uniform morphology and a whorled arrangement.
2) Cell number and activity : Use the AO/PI staining method to assess the number and viability of umbilical cord mesenchymal stem cells; the cell count shall exceed the specified minimum, and cell viability shall be ≥90%.
3) Sterile : The sterility of umbilical cord mesenchymal stem cells shall be assessed using the plate spreading method, and the sterility test result shall be negative.
4) Mycoplasma : Use the colorimetric method to detect mycoplasma contamination in umbilical cord mesenchymal stem cells; mycoplasma testing of umbilical cord mesenchymal stem cells should be negative.
5) Surface markers : Flow cytometry is used to detect surface markers of umbilical cord mesenchymal stem cells. The cells are considered to meet the criteria if the positive rates for CD73, CD90, and CD105 are ≥95%, and the positive rates for CD19, CD34, and CD45 are ≤5%.
6) Differentiation Potential Assay : To assess the in vitro differentiation potential of umbilical cord–derived mesenchymal stem cells (hUC-MSCs) into adipocytes, osteoblasts, and chondrocytes; differentiation capacity serves as a functional cell parameter and is used as a reference indicator, but the results are not to be regarded as quality standards for umbilical cord–derived mesenchymal stem cells.
HiXpan ® Brief Overview of the MSC Serum-Free Culture Kit
Product Advantages
Serum-free and free of xenogenic animal-derived components
Applicable to Multiple tissue sources human mesenchymal stem cells, such as umbilical cord MSCs, bone marrow MSCs, and adipose-derived MSCs
Faster proliferation capability, stability Passaged to more than 20 generations , to better maintain cellular differentiation potential
Use directly, No additional components are required. ， No coating of the culture plate is required.
The cells are small in size, and 20 million cells can be harvested within 72 hours of T175 culture.
1. HiXpan ® Under serum-free MSC culture conditions, umbilical cord-derived MSCs exhibit a shorter doubling time and yield a higher cell harvest after three consecutive passages.
Different brands of umbilical cords
MSC doubling time
Different brands of umbilical cords
MSC catch volume
2. HiXpan ® Under serum-free MSC culture conditions, umbilical cord-derived MSCs can effectively maintain their cellular characteristics and preserve a balanced lineage differentiation potential.
The positive rates for flow cytometric detection of the cell surface markers CD105, CD73, and CD90 were all in Over 98% ；
The positive rates of cell surface negative markers CD45, CD34, CD19, and HLA-DR are in Less than 1% 。
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