STEM CELLS Transl Med. 2021;1–14
Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial
Giacomo Lanzoni1,2 | Elina Linetsky1,3 | Diego Correa1,4 | Shari Messinger Cayetano5 | Roger A. Alvarez6,7 | Dimitrios Kouroupis1 | Ana Alvarez Gil1 | Raffaella Poggioli1 | Phillip Ruiz3 | Antonio C. Marttos6,7,8 | Khemraj Hirani1,6 | Crystal A. Bell6 | Halina Kusack6 | Lisa Rafkin1 | David Baidal1,6,7 | Andrew Pastewski8 | Kunal Gawri6,7 | Clarissa Leñero1 | Alejandro M. A. Mantero5 | Sarah W. Metalonis5 | Xiaojing Wang1 | Luis Roque1 | Burlett Masters1 | Norma S. Kenyon1 | Enrique Ginzburg3,7,8 | Xiumin Xu1 | Jianming Tan9 | Arnold I. Caplan10 | Marilyn K. Glassberg11 | Rodolfo Alejandro1,6,7 | Camillo Ricordi1,3
Correspondence Camillo Ricordi, MD, Diabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, 1450 NW 10th Ave., Miami, FL 33137, USA. Tel +1 305 582 7151; FAX +1 305 243 4404 Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti-inflammatory effects and could yield beneficial effects in COVID-19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UCMSC) infusions in subjects with COVID-19 ARDS. A double-blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty-four subjects were randomized 1:1 to either UC-MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC-MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC-MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours post infusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion-associated AEs. No serious adverse events (SAEs) were observed related to UC-MSC infusions. UC-MSC infusions in COVID-19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC-MSC-treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03). UC-MSC infusions are safe and could be beneficial in treating subjects withCOVID-19ARDS.
Biohellenika was audited online on 16/12/2020 and 17/12/2020 for continued international accreditation by the AABB (American Association of Blood Banks). The assessment was done online and took longer than normal, due to the virtual process. Biohellenika has successfully completed the two-day evaluation process and continues to belong to the internationally accredited cord blood stem cell banks. It is the 6th consecutive successful evaluation of Biohellenika by AABB and its renewal will take place in 2022.
Biohellenika renews the AABB accreditation continuously since 2010.
It is also in the process of being accredited by FACT NetCord, which is another international accreditation that includes the allogeneic use of stem cells.
It is also accredited by the National Accreditation System (ESYD) for all the tests provided by law, which are required for the storage of umbilical cord blood stem cells.
The company also completes the GMP (Good Manufacturing Practice) processes for its development into a Tissue Bank and a Biotechnology company.
Infusion of human umbilical cord tissue mesenchymal stromal cells in children with autism spectrum disorder
Jessica Sun1, Geraldine Dawson2, Lauren Franz2, Jill Howard2, Colleen McLaughlin1, Bethany Kistler1, Barbara Waters-Pick3, Norin Meadows1, Jesse Troy1, Joanne Kurtzberg1
1The Marcus Center for Cellular Cures, Duke University, Durham, North Carolina
2Duke Center for Autism and Brain Development, Duke University, Durham, North Carolina
3Stem Cell Transplant Laboratory, Duke University, Durham, North Carolina
Ongoing neuroinflammation may contribute to symptoms of autism spectrum disorder (ASD) in at least a portion of affected individuals. Mesenchymal stromal cells (MSCs) have demonstrated the capacity to modulate neuroinflammation, but safety and feasibility of MSC administration in children with ASD have not been well established. In this open-label, phase I study, 12 children with ASD between 4 and 9 years of age were treated with intravenous (IV) infusions of human cord tissue mesenchymal stromal cells (hCT-MSCs), a third-party MSC product manufacturedfrom unrelated donor umbilical cord tissue. Children received one, two, or three doses of 2 × 10(6) cells per kilogram at 2-month intervals. Clinical and laboratory evaluations were performed in person at baseline and 6 months and remotely at 12 months after the final infusion. Aside from agitation during the IV placement and infusion in some participants, hCT-MSCs were well tolerated. Five participants developed new class I anti-human leukocyte antigen (HLA) antibodies, associated with a specific lot of hCT-MSCs or with a partial HLA match between donor and recipient. These antibodies were clinically silent and not associated with any clinical manifestations to date. Six of 12 participants demonstrated improvement in at least two ASDspecific measures. Manufacturing and administration of hCT-MSCs appear to be safe and feasible in young children with ASD. Efficacy will be evaluated in a subsequent phase II randomized, placebo-controlled clinical trial.
STEM CELLS Transl Med. 2020;1–10. DOI: 10.1002/sctm.19-0434
Information on the coronavirus test in Biohellneika
In Biohellenika the coronavirus molecular test and the IgG and IgM antibody test are performed. The molecular test enables the detection of the RNA of the virus while the virus is in our body, even if it has not shown symptoms, or is in the phase of the disease and is completely diagnostic. A positive result shows that the patient transmits the virus and leads him directly to take measures for his health, but also to protect his environment. This test is performed on the nasopharyngeal fluid and the PCR method is applied in real time.
In Biohellenika we test 3 genes, the gene E, that belongs to the corona virus family, N and RdRP that are belong to SARS COV 2. If this test is negetive for E gene the patient is free of corona virus family. If this gene is positive we procced for testing of the second gene, E, RdRP, that are specific for the SARS-CoV-2. In the case that E or RdRPor both are positive, the patient is infected by the SARS-CoV-2, the virus that produce the current pandemia. If these genes are negative, it means that patient is infected by a member of corona virus family, but not of the virus that produce the current pandemia.
The antibody test for SARS-CoV-2 is performed in the blood serum. The antibodies show a recent or past infection with SARS-CoV-2 and their presence in the blood indicates immunity and perhaps protection against a new infection. The antibodies detected are of the IgM and IgG type.
Biohellenika and its scientific staff in order to ensure the reliability of the results cooperates with the company Roche diagnostics, which provides accredited and licensed products.
Biohellenika’s molecular test detects from 10 virus particles and above, while other tests detect from 100 and above. This means early diagnosis of the infection from the early stages and protection of the patient and his environment from the spread of the virus. The reliability of the test at Biohellenika is confirmed by external quality controls and is in the process of accreditation by the National Accreditation System (ESYD).
Based on the EODY, the results of the molecular test for the coronavirus are considered valid as long as they are performed in laboratories already accredited by ESYD for other mollecular tests. Biohellenika laboratories have been accredited by ESYD since 2008.
A Role for MSC to Treat Coronavirus Patients. Part 2: Fibrosis in Survivors
Author: Frances Verter, PhD
https://celltrials.org/news/role-msc-treat-coronavirus-patients-part-2-fibrosis-survivors
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