{"id":3065,"date":"2026-02-02T14:16:00","date_gmt":"2026-02-02T06:16:00","guid":{"rendered":"https:\/\/www.cytopeutics.com\/?p=3065"},"modified":"2026-02-02T21:15:57","modified_gmt":"2026-02-02T13:15:57","slug":"high-dose-of-intravenous-allogeneic-umbilical-cord-derived-mesenchymal-stem-cells-clv-100-infusion-displays-better-immunomodulatory-effect-among-healthy-volunteers-a-phase-1-clinical-study","status":"publish","type":"post","link":"https:\/\/www.cytopeutics.com\/zh-hans\/abstracts-publication\/wellness-aging-frailty\/high-dose-of-intravenous-allogeneic-umbilical-cord-derived-mesenchymal-stem-cells-clv-100-infusion-displays-better-immunomodulatory-effect-among-healthy-volunteers-a-phase-1-clinical-study\/\u00a0","title":{"rendered":"High Dose Of Intravenous Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells (Clv-100) Infusion Displays Better Immunomodulatory Effect Among Healthy Volunteers: A Phase 1 Clinical Study"},"content":{"rendered":"\t\t
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  1. NSCMH Medical Centre, Seremban, Malaysia<\/span><\/li>
  2. University Tunku Abdul Rahman University, Malaysia<\/span><\/li>
  3. Cytopeutics, Selangor, Malaysia<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Background <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Mesenchymal stem cells (MSCs) express growth factors and other cytokines that stimulate repair and control the immune response. MSCs are also immunoprivileged with low risk of rejection. Umbilical cord-derived MSCs (UCMSCs) are particularly attractive as an off-the-shelf allogeneic treatment in emergency medical conditions. We aim to determine the safety and efficacy of intravenous allogeneic infusion of UCMSCs (CLV-100) by Cytopeutics\u00ae (Selangor, Malaysia) in healthy volunteers, and to determine the effective dose at which an immunomodulatory effect is observed.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Methodology<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Umbilical cord samples were collected after delivery of full-term, healthy babies with written consent from both parents. All 3 generations (newborn, parents, and grandparents) were screened for genetic mutations, infections, cancers, and other inherited diseases. Samples were transferred to a certified Good Manufacturing Practice laboratory for processing. Subjects were infused with either low dose (LD, 65 million cells) or high dose (HD, 130 million cells) of CLV-100 and followed up for 6 months. We measured cytokines using ELISA including anti-inflammatory cytokines interleukin 1 receptor antagonist (IL-1RA), interleukin 10 (IL-10), pro-\/anti-inflammatory cytokine interleukin 6 (IL-6), and the proinflammatory cytokine tumor necrosis factor-alpha (TNF-\u03b1).\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Results<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    11 healthy subjects (LD, n = 5; HD, n = 6; mean age of 55 \u00b1 13 years) were recruited. All subjects tolerated the CLV-100 infusion well with no adverse reaction throughout the study especially in vital parameters and routine blood tests. At 6 months, the HD group had significantly higher levels of anti-inflammatory markers IL1-RA (705 \u00b1 160 vs. 306 \u00b1 36\u2009pg\/mL; p = 0.02) and IL-10 (321 \u00b1 27 vs. 251 \u00b1 28\u2009pg\/mL; p = 0.02); and lower levels of proinflammatory marker TNF-\u03b1 (74 \u00b1 23 vs. 115 \u00b1 15\u2009pg\/mL; p = 0.04) compared to LD group.\u00a0\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    Conclusion<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Allogeneic UCMSCs CLV-100 infusion is safe and well-tolerated in low and high doses. Anti-inflammatory effect is observed with a high-dose infusion. Mesenchymal stromal cells (MSCs) express growth factors and other cytokines that stimulate repair and control the immune response. MSCs are also immunoprivileged with low risk of rejection. Umbilical cord derived MSC (UCMSCs) are particularly attractive as off-the-shelf allogeneic treatment in emergency medical conditions.Allogeneic UCMSCs CLV-100 infusion is safe and well-tolerated in low and high doses. Anti-inflammatory effect is observed with high dose infusion.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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    \n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tDownload paper<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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