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Updated: Aug 11, 2026
An Efficient Method for Directed Hepatocyte-Like Cell Induction from Human Embryonic Stem Cells
Published on: May 6, 2021
Treatment with stem cell differentiation stage factors of intermediate-advanced hepatocellular carcinoma: an open
Tito Livraghi1, Franca Meloni, Alberto Frosi
1Department of Radiology, Civil Hospital of Vimercate, Vimercate, Milan, Italy.
Abstract:
There is no standard treatment for patients with advanced hepatocellular carcinoma (HCC). We developed a product containing stem cells differentiation stage factors (SCDSF) that inhibits tumor growth in vivo and in vitro. The aim of this open randomized study was to assess its efficacy in patients with HCC not suitable for resection, transplantation, ablation therapy, or arterial chemoembolization. A total of 179 consecutive patients were enrolled. We randomly assigned the patients to receive either SCDSF or only conservative treatment. Primary end points were tumor response and survival. Secondary end points were performance status and patient tolerance. Randomization was stopped at the second interim analysis (6 months) of the first 32 patients recruited when the inspection detected a significant difference in favor of treatment (p = 0.037). The responses to the therapy obtained in 154 additional patients confirmed previous results. Evaluation of survival showed a significant difference between the group of patients who responded to treatment versus the group with progression of disease (p < 0.001). Of the 23 treated patients with a performance status (PS) of 1, 19 changed to 0. The study indicated the efficacy of SCDSF treatment of the patients with intermediate-advanced HCC.
Insights
Stem cells differentiation stage factors (SCDSF) show promise for treating advanced hepatocellular carcinoma (HCC). This novel therapy demonstrated significant tumor inhibition and improved survival in patients ineligible for standard treatments.
Area of Science:
- Hepatocellular Carcinoma Research
- Stem Cell Therapy
- Oncology
Background:
- Advanced hepatocellular carcinoma (HCC) lacks a standard treatment protocol.
- Current treatment options for HCC are limited for patients unsuitable for resection, transplantation, ablation, or chemoembolization.
Purpose of the Study:
- To evaluate the efficacy of a novel stem cells differentiation stage factors (SCDSF) therapy.
- To assess SCDSF's impact on tumor response, survival, performance status, and patient tolerance in advanced HCC patients.
Main Methods:
- An open-label, randomized study involving 179 advanced HCC patients.
- Patients were randomized to receive either SCDSF treatment or conservative care.
- Study endpoints included tumor response, survival rates, performance status, and patient tolerance.
Main Results:
- Early interim analysis revealed a significant benefit favoring SCDSF treatment (p = 0.037).
- Subsequent patient data confirmed these positive findings, demonstrating significant survival differences between responders and non-responders (p < 0.001).
- A notable improvement in performance status was observed, with 19 out of 23 patients with PS 1 improving to PS 0.
Conclusions:
- Stem cells differentiation stage factors (SCDSF) demonstrate significant efficacy in treating intermediate-advanced hepatocellular carcinoma.
- SCDSF therapy offers a potential new treatment avenue for HCC patients who are not candidates for conventional therapies.
- The treatment positively impacts patient outcomes, including tumor control and performance status.
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