Recently, the international authoritative journal "Signal Transduction and Targeted Therapy" published the results of a Phase 1/2a single-arm clinical trial completed by Xiangya Hospital of Central South University and other institutions [1]. This clinical trial was designed to initially evaluate human Safety and effectiveness of umbilical cord mesenchymal stem cells in the treatment of psoriasis. It is reported that the clinical trial results are the first systematic clinical trial results released in this field worldwide, while previous reports were sporadic case reports.
What is psoriasis?
Psoriasis (commonly known as " psoriasis") is a common chronic relapsing inflammatory systemic disease that currently affects approximately .125 billion people worldwide. In China, the estimated prevalence of psoriasis is 0.47%, affecting more than million patients, resulting in a huge disease burden. It is the immune-related skin disease with the longest course and the greatest impact on quality of life. There is no cure. .
The disease mainly affects young adults and has a greater impact on the physical health and mental status of patients. The clinical manifestations are mainly erythema and scales, which can occur all over the body, and are more common on the scalp and extended sides of the limbs, and are often aggravated in winter.
Although major breakthroughs have been made in the field of psoriasis with targeted biologics and small molecule drugs, the pathogenesis of the disease remains unclear. Once biologic agents are discontinued, the disease often relapses. The immunomodulatory ability of mesenchymal stem cells and makes them promising to become a new clinical treatment method for immune-related diseases. There have been case reports of stem cell treatment of psoriasis in the world, but there is a lack of systematic and in-depth clinical research.
Research results
html On August 5, Xiangya Hospital of Central South University was the first communication unit, Professor of Dermatology of Xiangya Hospital of Central South University Chen Xiang, Chief Physician Kuang Yehong and Professor of the Institute of Reproductive and Stem Cell Engineering of the School of Basic Medicine of Central South University Lin Ge is the co-corresponding author of and published online the latest clinical research on human umbilical cord-derived mesenchymal stem cells in the treatment of psoriasis in the sub-journal of Nature magazine "Signal Transduction and Targeted Therapy" Thesis - "Human umbilical cord mesenchymal stem cells for psoriasis: A phase 1/2a, single-arm study" .
The basic and clinical translational research of stem cells has attracted much attention in today's life science research. This study is the first in the world to complete the Phase 1/2a single-arm clinical study of using UMSCs to treat psoriasis (registered clinical trial number NCT03765957) , evaluated the safety and efficacy of human UMSCs in treating psoriasis and preliminarily explored the possible mechanisms. This study by the scientific research team of Xiangya Hospital of Central South University found: Allogeneic human umbilical cord-derived mesenchymal stem cells (UMSCs) transplantation is safe and partially effective for psoriasis patients, especially female psoriasis patients; Low levels of baseline Treg cell numbers predict better treatment response and may be a predictive factor for UMSCs to effectively treat psoriasis.
This Xiangya Hospital is conducting a phase 1/2a single-arm clinical trial, aiming to evaluate the safety of human umbilical cord-derived mesenchymal stem cells (umbilical cord-derived MSCs, UMSCs) in the treatment of psoriasis. and effectiveness.
A total of 17 psoriasis patients received umbilical cord mesenchymal stem cell therapy. During the 6-month follow-up, no relevant serious adverse events occurred. In addition, 47.1% of patients who received treatment had at least a 40% improvement, 35.3% had an improvement of more than 75%, and 17.6% had a Psoriasis Area and Severity Index (PASI) improvement of more than 90%. Above [1].
- The first phase of clinical treatment: 5 psoriasis patients completed the treatment and received UMSCs injection every 2 weeks, a single dose of 1.5 × 10^6/kg, 4 times as a course of treatment, 15 days and 30 days after treatment , 45 days, 2 months, 3 months, and 6 months follow-up.
- Phase II clinical treatment: From September 2019 to August 2020, 12 psoriasis patients completed treatment and received 4 doses of increasing doses of UMSCs (1.5, 2.0, 2.5, 3.0 × 10^6/kg). , divided into four groups ABCD; patients in groups A and B were intravenously infused with UMSCs once every 15 days, with 4 times as one course of treatment; patients in groups C and D were infused with UMSCs once every 30 days, with 2 times being 1 A course of treatment.
Safety
No significant side effects were observed during treatment and follow-up.
Even patients who received UMSCs infusion with cell numbers as high as 2.4×10^8 (3.0×10^6/kg dose group) showed no obvious side effects after the infusion, including fever and thrombosis.
Effectiveness
The effective rate for women is 66.7% (6/9), and the effective rate for men is 25% (2/8).
7.1% (8/17) of psoriasis patients had at least a 40% improvement in lesion area and severity scores.
7.6% (3/17) of patients had no signs of disease or very mild disease.
No significant correlation was found between the therapeutic effect of UMSCs and the dose of a single infusion.
html Representative skin images of 13 typical patients before and after treatment
In summary, this human clinical trial demonstrates that allogeneic UMSCs are safe and effective in the treatment of psoriasis.
Outlook
Psoriasis is known as the "unkillable devil". Once it becomes sick, it will relapse repeatedly, causing serious trouble to patients. Conventional treatment methods are ineffective. With the introduction of stem cell therapy, the dilemma of psoriasis treatment has been solved to a certain extent. Stem cells can promptly correct the imbalanced immune status in patients with psoriasis by virtue of their powerful immunomodulatory properties. Currently, some clinical studies on stem cell treatment of psoriasis are underway, many of which are conducted by Chinese research teams. In the future, in addition to conducting more clinical studies to verify its safety and efficacy, it is also necessary to reach a consensus on stem cell treatment mechanisms, optimal cell sources, administration routes and dosages.
Reference:
[1]Cheng L, Wang S, Peng C, et al. Human umbilical cord mesenchymal stem cells for psoriasis: a phase 1/2a, single-arm study. Signal Transduct Target Ther. 2022;7(1 ):263. Published 2022 Aug 5.
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