Stroke patient recovers after cord blood infusion from StemCyte
March 2022 Jonas Wang, PhD, & Bill Williams StemCyte is excited to announce the remarkable recovery of a patient who had been paralyzed on one side of his body as the result of a stroke. This patient received an infusion of a matching cord blood unit from the StemCyte public bank. Within a year, he had regained full motor function and images of his brain show that the swelling caused by the stroke had resolved. This case report was published in the peer-reviewed scientific journal CELL TRANSPLANTATION on 23 December 2021.
Acute stroke is the 2nd leading cause of death and 3rd leading cause of disability worldwide1. More than 15 million people suffer from a stroke annually. Approximately 30% - 35% of these patients die and nearly 75% of survivors sustain permanent disability. In ischemic stroke, a blood vessel in the brain is blocked. The best current treatment for ischemic stroke is to infuse thrombolytic agents to break down blood clots and increase blood flow to the brain. However, this intervention is strongly time-dependent: for every minute that treatment is delayed, 2 million nerve cells die in the patient’s brain2. In the United States, the optimal time window for stroke intervention has been dubbed the “Golden Hour” after onset of stroke. StemCyte registered a clinical trial NCT02433509 in cooperation with doctors at Taiwan’s Tzu Chi University Hospital that was designed to test the ability of cord blood infusions to help stroke patients. Although the trial was first registered in 2015, it has been difficult to enroll patients because of the requirement that they must find ischemic stroke victims that had missed the window for administration of anti-clotting drugs. The goal of the researchers is to measure the impact of the cord blood infusion alone, with no other stroke intervention in the patient’s system. In June of 2019, a 46-year-old male patient came to the hospital suffering from a stroke that had begun two hours earlier. This patient had a history of chronic high blood pressure and had been on dialysis for end stage kidney disease since 2011. The doctors realized that he was a candidate for the cord blood study and immediately obtained a baseline MRI image of his brain. Cord blood stem cells have several advantages over products that must be manufactured from the blood of the patient or from adult donors. There are the obvious practical advantages that cord blood products are already in storage, without having to find a donor, collect cells from the donor, and screen for diseases. Plus, cord blood products are much less likely to trigger a graft versus host reaction than blood cells from adult donors. Moreover, the authors of the StemCyte study present evidence that cryopreserved cord blood is significantly richer than adult blood in anti-inflammatory proteins that enable cells to communicate and significantly richer in cell growth factors1. StemCyte found a cord blood unit that matched the 46-year-old stroke patient at 6 out of 6 HLA types. The cord blood came from a baby that was born in Taiwan in July 2002, 17 years earlier! The cord blood had been processed with a plasma depletion method and had a total mononuclear cell count of 263 million. By the time the unit had been tested, transferred, thawed, and prepared for infusion, it was given to the patient on the 8th day after his stroke. In addition, the patient received four 100mL infusions of mannitol, starting a half hour after the cord blood and every 4 hours thereafter. Mannitol is a diuretic that is frequently given to patients suffering from traumatic brain injury, to lower their intracranial pressure. The images show magnetic resonance images (MRIs) of the stroke patient’s brain that were taken 2 hours after the stroke, 1 day after the umbilical cord blood (UCB) transfusion, 3 months after UCB transfusion, and 6 months after UCB transfusion. These MRI’s were taken with Diffusion-Weighted Imaging (DWI), which is a technique that highlights brain swelling and can accurately detect ischemic stroke within minutes of onset5. The images clearly show that the edema (swelling from excess fluid) in the right lobe of the patient’s brain disappeared within 6 months after the cord blood infusion. The true test of how well a therapy treats stroke is when a patient regains skills that had been impaired. In this case the patient was experiencing paralysis on the left side of his body (hemiplegia) as a result of the infarction on the right side of his brain. The patient began to regain mobility after the cord blood infusion, and by the third month he could walk with limited assistance. The patient was followed for one year following cord blood therapy. During this time his score on the NIH Stroke Scale (NIHSS) decreased from 9 to 1, the Berg Balance Scale score increased from 0 to 48; and the Barthel index which scores activities of daily living increased from 0 to 90 over the one year follow up. At the end of the observation period, the patient had fully recovered his motor functions and could live independently. Whereas most stroke patients are left with permanent disabilities, especially if they are not treated within the Golden Hour after stroke, this patient fully recovered after a simple cord blood infusion on the 8th day after his stroke. This could open a new landscape of hope for stroke patients around the world. This case report also demonstrates the potential value of cord blood donations sitting in public banks, even donations from decades ago. Whereas cord blood donations have long been promoted as a life-saving therapy for patients with blood cancers, they might have even broader application as a therapy for stroke patients.
StemCyte offers both public and private cord blood banking to parents in the United States, Taiwan, and India. To learn more about cord blood banking, visit Parent's Guide to Cord Blood Foundation at https://parentsguidecordblood.org/en/news/stroke-patient-recovers-after-cord-blood-infusion-stemcyte
Source/Disclosures
Stem cell transplantation may treat aggressive MS long term
WEST PALM BEACH, Fla. — Autologous hematopoietic stem cell transplantation had long-term effectiveness for treating aggressive MS, according to results of a retrospective observational study presented at the ACTRIMS Forum.
“The objective was to determine if the bone marrow transplant was effective and safe at long term,” Francis Brunet, of the MS clinic at Ottawa General Hospital in Canada, said during a presentation.
Specifically, Brunet and colleagues sought to examine whether autologous hematopoietic stem cell transplantation (aHSCT) led to durable disease remission and safety by analyzing short- and long-term outcomes from the Ottawa cohort. They retrospectively studied outcomes of 72 patients with aggressive MS who received aHSCT for MS at a single center between October 2001 and February 2021 and who were monitored for at least 6 months. Busulfan plus cyclophosphamide followed by anti-thymocyte globulin post-transplant of a CD34+ selected graft composed the conditioning regimen used for aHSCT.
The number of new clinical relapses following the transplant served as the primary outcome and new MRI lesions, overall survival and safety as the secondary outcomes. Further, researchers examined the relationship between baseline Expanded Disability Status Scale (EDSS) scores and the evolution of the same over time.
Results showed 62 patients had relapsing-remitting MS, eight had secondary progressive MS and two had primary progressive MS, with follow-up ranging between 8 months and 20 years. During the follow-up period, Brunet and colleagues reported no new relapse. They noted there were 206 relapses, or 1.1 relapses per patient per year, pre-transplant, with 195.9 patient-years of follow-up. Further, they noted zero relapses post-transplant, with 288 patient-years of follow-up. No patient received another form of disease modifying treatment.
Brunet and colleagues reported one death 27 days after aHSCT due to sepsis and veno-occlusive disease of the liver. One other patient died of pneumonia 67 months after aHSCT. Although MRI scans were not performed regularly during follow-up, no new lesions were reported post-transplant. Patients with a lower baseline EDSS score more often had EDSS reductions post-transplant. Among 26 patients with baseline EDSS less than five, 13 had improvements in EDSS scores vs. six with a baseline EDSS greater than or equal to five.
“Bone marrow transplant is effective for patients who are adequately selected, and the key is to try to identify which patient will be the best candidate,” Brunet said. “If you have a patient who failed the standard DMT, think about the transplant and evaluate the patient and see if they will have the best outcome or not depending on their situation.”
The Granddaughter Donated Newborn Stem Cells to her Grandfather after a Stroke January 2021
The 60-year-old father suffered a serious stroke in September 2018. According to the World Stroke Organization, 1 in 4 adults over the age of 25 will have a stroke in their lifetime. This year, 13.7 million people worldwide will have their first stroke, and 5.5 million of them will die as a result1. In the United States, someone has a stroke every 40 seconds 2,3. “Dad had a stroke two years ago, and eight hours later, Mom found him at home in the bedroom. He was conscious, but his condition was very serious.” Lucie’s father was taken to a hospital near Brno, Czech Republic, where he received medication to disperse a clot in his carotid artery. The stroke affected her father’s left cerebral hemisphere, causing significant paralysis and sensory disturbances in the right half of his body as well as the speech center. After a month in the hospital, the doctors told the family they could do no more, that it was time for Lucie’s father to go home or enter a long-term care facility. “The doctors subsequently told us that my father would remain mentally handicapped, that he would not know us, that he would not be able to live independently and that he would be bedridden.” recalls Lucie. Lucie did not want her mother’s life to hold nothing but the constant work of taking care of her severely handicapped father. The family arranged for their father to stay for three months in a rehabilitation institute in Kladruby (east of Prague). There, he got up from his bed and began to undergo physical rehabilitation, learning personal hygiene, dressing himself, and eating with his left hand. He also learned to use a wheelchair and to walk again with assistance. "I don't think I would call it an improvement”, Lucie says of the first months of rehabilitation, because she was frustrated that the progress focused on physical skills but not cognitive skills. "He didn't know the colors, he couldn't read, he didn't know the numbers… I definitely wasn't going to put up with it”, adds Lucie. In April 2019, Lucie happened to see a TV show Pošta pro tebe, in which a gentleman talked about his improvement after cell therapy. "It simply came to my notice then. I started looking for, studying what and how umbilical cord and blood cells can be used and what they could improve”, says Lucie. She also contacted stem cell clinics. "I investigated all the risks and I was told that his condition could not worsen after the application of these cells," she adds. Therapy with both umbilical cord blood and umbilical cord tissue Less than a month later, the family took their father to a clinic in Slovakia for therapy with newborn stem cells. Lucie explained, "I chose the clinic because they use neonatal cells derived from umbilical cord blood and umbilical cord for treatment. Logically, it occurs to me that these cells, because they are new and unworn, will probably be better than dad getting his own, which are simply old". The therapy used both hematopoietic stem cells from umbilical cord blood as well as mesenchymal stromal cells from umbilical cord tissue. The cells were administered both by intravenous infusion and by intrathecal injection into the spinal canal. The first course of therapy used cells from an unrelated donor baby. In addition to the cell therapy, Lucie’s father continued to receive physical therapy with professionals. In late 2019, he stayed for a second course of treatment. Τhere the staff remembered him from his stay a year before, and stated that he had made tremendous progress. For example, his walking was improved to the point that he did not need support. Most important for the family, their father’s cognitive skills greatly improved. In his speech therapy, he began to articulate more, and could control his mouth to speak the letters that the speech therapist asked him to pronounce. "I see a shift in routine things he hasn't done before. When his food crumbs fall, he stops eating and starts cleaning up after himself" noted Lucie. The second course of therapy at the end of 2019 came from the patient’s granddaughter. Seeing the improvement from the first therapy, a second therapy was considered to push the progress further. But since Lucie was pregnant in 2019, everyone decided to wait for the birth of the granddaughter so that she could donate her blood and tissue cells to her grandfather. "When we went to Slovakia for the first time, I informed my father that he would have a granddaughter, so he had to try and be motivated to be able to take care of her when she was born. From the first moment I saw the report on TV, I didn't stop believing that my dad wouldn't give up. And when I saw that my dad wanted to fight and wanted to live, I didn't give up and I wanted to have a slightly normal life for him." Lucie advices to other expectant parents: "I think that mothers should find out during pregnancy what can be used for preserved umbilical cord blood. You never know what might happen to your family tomorrow or maybe in 10 years and when you may need cells. If I were pregnant again, I would definitely keep my umbilical cord blood." References World Stroke Organization. Learn About Stroke. Accessed Jan. 2020 Virani SS, Alonso A, Benjamin EJ, et al. On behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation 2020; 141(9):e139–e596. CDC. Stroke Facts. Last updated 20200908 Comments Disclaimer To learn more about cord blood banking, visit Parent's Guide to Cord Blood Foundation at https://parentsguidecordblood.org/en/news/granddaughter-donated-newborn-stem-cells-her-grandfather-after-stroke
Biohellenika today renewed its license as a Umbilical Cord Blood Bank in accordance with the new Terms and Conditions and the intention of the Ministry of Health to complete the procedures for those banks that meet the requirements.
Respecting the decision of the parents to keep the stem cells of their children, Biohellenika took care to offer them the most complete and quality services. For this reason it recently renewed its international accreditation from AABB (American Association of Blood Banks) and has proceeded to the second international accreditation by FACT NetCord. This second accreditation is expected to be completed in the next two years.
It also has the most complete accreditation system by the ESYD (National Accreditation System), which includes all the tests required for the storage of stem cells, according to the Terms and Conditions.
At the same time it perfects the GMP system (good practice) of laboratories for the production of cell therapy products.
Biohellenika has a strong Research and Development Department and a strong medical team, which can support clinical trials using stem cells for serious diseases.
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.
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