Stem cells on the remote
A new study shows the effectiveness of treatment with mesenchymal stem cells (MSCs) ex vivo, that is, outside the body. The SBI-101 delivery system allowed the cells to remain viable longer and modulate the peripheral immune response to restore the kidneys.
Acute renal failure is a condition in which the kidney suddenly stops filtering blood, leading to a dangerous accumulation of toxic metabolites in it. In the most severe cases, dialysis or kidney transplantation is required, and mortality reaches 50-70 percent.
Inflammation is a key factor in the pathogenesis of acute renal failure. Inflammatory mediators disrupt the regulation of the immune system, triggering a "cytokine storm" that damages the kidneys and other organs. Modern methods of treatment are not able to completely eliminate these inflammatory reactions.
Restoring the balance of inflammatory proteins with cellular immunotherapy can break the vicious circle of autoimmune reactions and restore organ functions. Researchers from Sentien Biotechnologies conducted a multicenter phase 1b clinical trial across the United States to test the new SBI-101 system.
MSCs secrete several types of molecules that regulate the response of immune cells to inflammation and, therefore, have great potential for use in regenerative medicine. However, MSCs administered by the usual intravenous method usually settle and break down in the lungs and are not detected in the body almost immediately after administration.
In search of a more effective method of delivery of MSCs, an innovative ex vivo delivery system SBI-101 was created, which is a combination of "ready-made" MSCs and an FDA-approved blood filtration device to improve and control the effects of MSCs. This design allows you to regulate the functions of blood cells outside the body, thereby maintaining the viability of MSCs throughout the treatment.
In fact, SBI-101 behaves like a living tissue that works outside the body to regulate inflammation in the patient's bloodstream using natural growth factors, cytokines and chemokines to normalize immune signals and functions.
The phase 1 study made it possible to evaluate the safety, tolerability and pharmacology of SBI-101 in adult patients with life-threatening renal insufficiency who were already on dialysis. 16 volunteers were recruited for the study. 12 received SBI-101 treatment along with the standard continuous renal replacement therapy (RRT) regimen, while four received fictitious SBI-101 along with RRT. The treatment lasted at least 12 hours and no more than 24 hours. HRT is a slower form of dialysis that puts less strain on the heart. Treatment usually lasts 24 hours, as opposed to four hours of normal dialysis procedures.
The patients' condition was assessed within 28 days after treatment. The examination showed that the MSCs were viable during all 24 hours of therapy, as evidenced by the measured levels of secreted factors. This confirms the longer-lasting effect of therapy than with the intravenous route of administration of MSCs.
In addition, SBI-101 promoted an immunotherapeutic response that was associated with a reduction in kidney damage. No serious side effects associated with SBI-101 were noted.
The results obtained prove that SBI-101 can affect the peripheral immune response, which can be activated by local tissue damage in vital organs, including the kidneys. This study demonstrates a safe and potentially effective clinical approach that can change the outcomes and prognosis of acute renal failure.
Article by M.Swaminathan et al. Pharmacological effects of ex vivo mesenchymal stem cell immunotherapy in patients with acute kidney injury and underlying systemic inflammation is published in the journal Stem Cells Translational Medicine.
Aminat Adzhieva, portal "Eternal Youth" http://vechnayamolodost.ru based on EurekAlert: Researchers report on a new way to deliver healing stem cells to kidney injury patients.