Category Archives: Stem Cells

In the United States, the most common of the aggressive non-Hodgkin lymphomas (NHLs) is diffuse large B-cell lymphoma (DLBCL), which accounts for between 22% and 24% of newly diagnosed B-cell NHL cases.1 Although DLBCL can affect children and young adults, it is most commonly diagnosed in individuals between the ages of 65 and 74 years, with a median age at diagnosis of 66 years.2,3 Given the aggressive nature of DLBCL, patients often present with lymphadenopathy, extranodal involvement, and other constitutional symptoms thatrequire immediate treatment.1

The treatment spectrum for DLBCL has expanded significantly in recent years, particularly for patients with relapsed or refractory (R/R) disease. Mechanisms of action differ greatly among agents, reflecting the complex pathophysiology and genetic variations of the disease. This article reviews the advances in DLBCL understanding that have led to the approval of new agents andsubsequent utilization of new mechanisms.

The current standards of care for first-line DLBCL treatment include the combination chemoimmunotherapy regimen of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP). The varying numbers of cycles and use in combination with or without radiotherapy (RT) depends upon the stage of disease at presentation.1 The addition of rituximab to CHOP was associated with a 2-year event-free survival of 57% in elderly patients in a 2002 randomized trial (LNH-98.5), which, along with results of other trials, led to the FDA approval of this combination therapy.4,5 Although durable remission can be achieved with R-CHOP in about 60% of patients, its use has resulted in poorer long-term outcomes for patients with double-hit andtriple-hit lymphomas (DHL and THL).1

In 2007, the International Harmonization Project issued guidelines on malignant lymphoma response criteria, defining relapsed disease as consisting of new lesions greater than 1.5 cm in any axis during or after the completion of therapy or a 50% or greater increase in the sum of the product of diameters of a previously involved node(s) or other lesion(s).6 The authors also defined refractory, or progressive, disease as entailing a 50% or greater increase in the size of a lymph node with a prior short-axis diameter of less than 1.0 cm to a size of 1.5 cm 1.5 cm (or a long-axis size of > 1.5 cm).6

For patients with R/R disease, high-dose chemotherapy and autologous stem cell transplant (ASCT) may offer the chance for cure, but several factors may limit the utility of this approach. For example, in the treatment of patients with MYC-positive R/R DLBCL, ASCT is considered controversial because it has produced poorer outcomes in patients with DHL.1 Additionally, patients who are older or have comorbidities may be inappropriate candidates for this approach,7 and patients with disease that is unresponsive to second-line chemotherapy may have poorer prognoses (ie, poorer rates of long-term survival) and incur added toxicity from the chemotherapy.7 Even when including patients who undergo high-dose, salvage chemotherapy and subsequent ASCT, patients with R/R DLBCL have a 1-year survival rate of 28%.1 Hence, in a search for improved outcomes in the R/R setting, clinical studies have focused on DLBCL subtypes, especially in those ineligible for transplant or who have relapsed following transplant.1

Another option for patients in the relapsed setting is chimeric antigen receptor (CAR) T-cell therapy, which entails the genetic modification of autologous T cells via cloned DNA plasmids carrying a viral recombinant vector in addition to T-cell receptor-expressing genes. CAR T-cell therapy plays an important role in the R/R DLBCL setting, with reported 2-year remissions and a complete response (CR) rate in 40% of patients and 25% DHL/THL patients.1 Other therapeutic classes that have been explored for DLBCL include phosphoinositide 3-kinase (PI3K) inhibitors, B-cell lymphoma 2 (BCL2) inhibitors, and checkpoint inhibitors.1,8-10

Given reduced survival in patients who are unresponsive to subsequent lines of therapy and the toxicity involved, a great need exists for novel agents in the R/R DLBCL setting. Recent entrants to the R/R DLBCL treatment landscape include the antibody-drug conjugate (ADC) polatuzumab vedotin-piiq, the selective inhibitor of nuclear export, selinexor, and the monoclonal antibody tafasitamab-cxix (TABLE 111-20).

Polatuzumab vedotin-piiq was approved by the FDA in 2019 and is indicated in combination with bendamustine and rituximab in adults with RR DLBCL not otherwise specified, following at least 2 previous therapies.11 It is an ADC wherein the monoclonal antibody is linked to an antimitotic agent, monomethyl auristatin E (MMAE). The ADC targets the B-cell surface protein CD79B and, after binding to the surface protein, is internalized by the cell. Lysosomal enzymes then cleave the link between the antibody and MMAE, the latter of which binds microtubules, thereby inhibiting cell division and inducing apoptosis.11

A 2020 phase 1b/2 study (NCT02257567) randomized patients with R/R DLBCL who were ineligible for ASCT to receive polatuzumab vedotin-piiq with bendamustine and rituximab (pola-BR) or bendamustine and rituximab (BR) alone.12 The phase 2 primary end point was CR; secondary end points included overall response rate (ORR) at end of treatment, superior overall response, duration of response (DOR), and progression-free survival (PFS) assessed per independent review committee (IRC).12 With a median follow-up of 22.3 months, the CR was significantly higher in the pola-BR group (40% vs 17.5% in the BR group; P = .026).12 Overall survival rate was also significantly higher in the pola-BR group (12.4 vs 4.7 months in the BR group; HR, 0.42; 95% CI, 0.24-0.75; P = .002).12 Similarly, median PFS was significantly longer at 9.5 months in the pola-BR group compared with 3.7 months in the BR group (HR, 0.36; 95% CI, 0.21-0.63; P < .001).12 Also, DOR was longer at 12.6 months in the pola-BR group vs 7.7 months in the BR group (HR, 0.47; 95% CI, 0.19-1.14).12 Finally, the pola-BR group had a 58% reduction in risk of death compared with the BR group (HR, 0.42; 95% CI, 0.24-0.75; P = .002).12 In terms of safety, grade 3/4 anemia, neutropenia, thrombocytopenia, and peripheral neuropathy occurred more frequently in the pola-BR group than in the BR group.12 Polatuzumab vedotin-piiq was deemed an effective agent that might provide a therapeutic option for patients with R/R DLBCL who were not ideal candidates for CAR T-cell therapy.12

In 2020, selinexor was approved by the FDA for use in adult patients with R/R DLBCL (including follicular lymphoma-derived DLBCL) after at least 2 lines of systemic treatment.13 Selinexor inhibits nuclear export of tumor suppressor proteins by blocking exportin 1.13

The FDA approval was based on results of the open-label single-arm phase 2 SADAL trial (NCT02227251), which included patients 18 years or older with DLBCL (based on pathologic confirmation) with an Eastern Cooperative Oncology Group (ECOG) score of 2 or less, who had 2 to 5 lines of prior therapy, and who had progressed following or were ineligible for ASCT.14 The primary end point of the SADAL trial was ORR (comprising patients with CR or PR per 2014 Lugano criteria), with secondary end points consisting of DOR and disease control rate.14 Patients received the 60-mg oral selinexor on the first and third day of each week until disease progression or unacceptable toxicity occurred.14

The updated phase 2b ORR was 28.3% with a disease control rate of 37% (95% CI, 28.6-46.0). Of 36 responders, CRs were reported in 13 evaluable patients and PRs were reported in 23 patients. At a median follow-up of 11.1 months, the median DOR was 9.3 months (95% CI, 4.8-23.0). For those with a CR, median DOR was 23.0 months (95% CI, 10.4-23.0); median DOR was 4.4 months for those with a PR (95% CI, 2.0not evaluable).14,15 To address potential differences by subtype, the SADAL trial also included a subgroup analysis of patients with the germinal center B-cell (GCB)like subtype (n = 59), which demonstrated an ORR of 33.9%, a 14% CR rate, and a 20% PR rate, whereas the patients with a non-GCB subtype (n = 63) had an ORR of 20.6%. At the time of data cutoff, 7%(n = 9) of patients showed continuing response.14,15 The SADAL trial also included 5 patients with the unclassified subtype, in 1 of whom a CR was achieved and in 2 of whom a PR was achieved.15With respect to safety, 98% of patients in the SADAL trial had at least 1 treatment-emergent adverse event (TEAE). The most frequent grade 3/4 events were thrombocytopenia, neutropenia, anemia, fatigue, hyponatremia, and nausea.14 Among serious AEs affecting 48% of patients, the most common were pyrexia, pneumonia, and sepsis.14 Gastrointestinal AEs werereported in 80% of patients, hyponatremia in 61%, and central neurologic events (which included dizziness and altered mental status) in 25%.16 Trial investigators concluded that selinexor improved survival considerably and that it presented a nonchemotherapy oral option for patients with R/R DLBCL.14

Tafasitamab-cxix is a CD19-targeting monoclonal antibody that gained FDA approval in 2020 for use with lenalidomide in adults with R/R DLBCL who are ineligible for ASCT, including patients with low-grade lymphoma derived DLBCL.17 Tafasitamab-cxix binds to the pre-B and mature B-lymphocyte surface antigen CD19, which is expressed in DLBCL and other B-cell malignancies.17 Tafasitamab-cxix, once bound to CD19, facilitates B-lymphocyte lysis via apoptosis and immune effector mechanisms that encompass antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.17

The FDA approval of tafasitamab-cxix was based on data from the phase 2, single-arm, multicenter, open-label L-MIND trial (NCT02399085).17,18 The L-MIND trial included patients 18 years or older with R/R DLBCL who had received 1 to 3 previous therapies ( 1 of which incorporated a CD20-directed regimen), had an ECOG score of 0 to 2, and were ASCT ineligible.18 Patients were administered tafasitamab-cxix and lenalidomide in 28-day cycles and continued to receive tafasitamab-cxix every 2 weeks after cycle 12 until disease progression.18 Objective response rate (ie, PR and CR) was the primary end point per IRC, which implemented PET imaging; secondary end points included investigator-assessed objective response rate, DOR, OS, PFS, biomarker analyses, and safety.18 Eighty patients were included in the full analysis set (FAS), receiving tafasitamab-cxix plus lenalidomide.18 Of the FAS, the objective response rate was 60.0% (95% CI, 48.4%-70.8%) and the CR rate was 42.5% (34/80).18 The rate of patients achieving a 12-month DOR rate was comparable across subgroups, with 70.5% of patients who received 1 prior line of therapy achieving a 12-month DOR (95% CI, 47.2%-85.0%) and 72.7% of patients who had 2 or more prior lines of therapy achieving a 12-month DOR (95% CI, 46.3%-87.6%).18

Outcomes in patients with GCB DLBCL (n = 37) were promising, with an objective response rate of 48.6%, a 12-month DOR rate of 53.5%, and a 12-month OS rate of 65.4% (based upon the Hans algorithm). Outcomes in patients with non-GCB DLBCL (n = 21) were an improvement over those with the GCB subtype, with an objective response rate of 71.4%, a 12-month DOR rate of 83.1%, and a 12-month OS rate of 84.2%.18 IRC-evaluated data from a 2-year follow up of the L-MIND trial showed an objective response rate of 58.8% (47/80) and CR rate of 41.3% (33/80).19 The 2-year follow up data also showed a median DOR of 34.6 months, with a 31.6-month median OS and a 16.2-month median PFS.19

Safety data from the preliminary L-MIND trial results showed that the most frequent TEAEs (of any grade) were neutropenia (48%), thrombocytopenia (32%), anemia (31%), diarrhea (30%), pyrexia (22%), and asthenia (20%).20 A lenalidomide dose reduction was required in 42% of patients; 72% of patients could remain on daily lenalidomide at 20 mg or higher.20 Trial investigators concluded that the combination of tafasitamab-cxix and lenalidomide was well tolerated and did not lead to compounded AEs.20

The promising data from recent trialsparticularly from their DLBCL subtype based subgroupsunderscore the importance of understanding the unique prognoses and responses that these subtypes confer on patient outcomes. The establishment of DLBCL subtypes as prognostic and therapeutic response factors has fueled a search for more specific molecular targets in the disease process. In addition, the importance of subtype characterization is evidenced by ongoing diagnostic assay development (for use in conjunction with immunohistochemistry). As exemplified by the patient populations in these trials, new therapeutic options with distinct mechanisms of actions are needed for patients with R/R DLBCL who are ineligible for ASCT. Multiple studies of targeted agents in the R/R DLBCL setting are under way that include CAR T-cell, bispecific T-cell engager, programmed death receptor 1 (PD-1) inhibitor, and BCL2 inhibitor therapies.1 Continued development of clinically applicable diagnostics holds promise for improved prognostic capability and assessment of therapeutic response. With improved diagnostics, further elucidation of DLBCL-driver mutations can continue to provide additional DLBCL subtype-specific options and, hence, more treatments tailored to individual patients.

References1. Liu Y, Barta SK. Diffuse large B-cell lymphoma: 2019 update on diagnosis, risk stratification, and treatment. Am J Hematol. 2019;94(5):604-616. doi:10.1002/ajh.254602. Diffuse large B-cell lymphoma. Lymphoma Research Foundation. Accessed October 12, 2020. https://lymphoma.org/aboutlymphoma/nhl/dlbcl/3. Cancer stat facts: NHL diffuse large B-cell lymphoma (DLBCL). National Cancer Institute. Accessed October 12, 2020. https://seer.cancer.gov/statfacts/html/dlbcl.html4. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large B-cell lymphoma. N Engl J Med. 2002;346(4):235-242. doi:10.1056/NEJMoa0117955. Rituxan plus CHOP approved for diffuse large B-cell lymphoma. Cancer Network. February 28, 2006. Accessed November 6, 2020. https://www.cancernetwork.com/view/rituxan-plus-chop-approved-diffuse-large-b-cell-lymphoma6. Cheson BD, Pfistner B, Juweid ME, et al; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25(5):579-586. doi:10.1200/JCO.2006.09.24037. Elstrom RL, Martin P, Ostrow K, et al. Response to second-line therapy defines the potential for cure in patients with recurrent diffuse large B-cell lymphoma: implications for the development of novel therapeutic strategies. Clin Lymphoma Myeloma Leuk. 2010;10(3):192-196. doi:10.3816/CLML.2010.n.0308. Oki Y, Kelly KR, Flinn I, et al. CUDC-907 in relapsed/refractory diffuse large B-cell lymphoma, including patients with MYC-alterations: results from an expanded phase I trial. Haematologica. 2017;102(11):1923-1930. doi:10.3324/haematol.2017.1728829. Ansell S, Gutierrez ME, Shipp MA, et al. A phase 1 study of nivolumab in combination with ipilimumab for relapsed or refractory hematologic malignancies (CheckMate 039). Blood.2016; 128(22):183. doi:10.1182/blood.V128.22.183.18310. Lesokhin AM, Ansell SM, Armand P, et al. Nivolumab in patients with relapsed or refractory hematologic malignancy: preliminary results of a phase Ib study. J Clin Oncol. 2016;34(23):2698-2704. doi:10.1200/JCO.2015.65.978911. POLIVY. Prescribing information. Genentech, Inc; 2020. Accessed October 22, 2020. https://www.gene.com/download/pdf/polivy_prescribing.pdf12. Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2020;38(2):155-165. doi:10.1200/JCO.19.0017213. XPOVIO. Prescribing information. Karyopharm Therapeutics, Inc; 2020. Accessed October 22, 2020. https://www.karyopharm.com/wp-content/uploads/2019/07/NDA-212306-SN-0071-Prescribing-Information-01July2019.pdf14. Kalakonda N, Maerevoet M, Cavallo F, et al. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020;7(7):e511-e522. doi:10.1016/S2352-3026(20)30120-415. Karyopharm reports updated data from the phase 2b SADAL study at the 2019 International Conference on Malignant Lymphoma. News release. Karyopharm. June 19, 2019.Accessed June 28, 2020. https://www.globenewswire.com/news-release/2019/ 06/19/1871363/0/en/Karyopharm-Reports-Updated-Data-from-the-Phase-2b-SADAL-Study-at-the-2019-International-Conference-on-Malignant-Lymphoma.html16. FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma. News release. FDA. June 22, 2020. Accessed June 28, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selinexor-relapsedrefractory-diffuse-large-b-cell-lymphoma17. Monjuvi. Prescribing information. MorphoSys US Inc; 2020. Accessed October 22, 2020. https://www.monjuvi.com/pi/monjuvi-pi.pdf18. Duell J, Maddocks KJ, Gonzalez-Barca E, et al. Subgroup analyses from L-Mind, a phase II study of tafasitamab (MOR208) combined with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Blood. 2019;134(suppl 1):1582. doi:10.1182/blood-2019-12257319. MorphoSys and Incyte announce long-term follow-up results from L-MIND study of tafasitamab in patients with r/r DLBCL. News release. Morpho-Sys. May 14, 2020. Accessed June 26, 2020. https://www.morphosys.com/media-investors/media-center/morphosys-and-incyte-announce-long-term-follow-up-results-from-l-mind20. Salles GA, Duell J, Gonzlez-Barca E, et al. Single-arm phase II study of MOR208 combined with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: L-Mind. Blood. 2018;132(suppl 1):227. doi:10.1182/blood-2018-99-113399

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New Approaches to the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma - Targeted Oncology

Global Synthetic Stem Cells Industry Report 2020 is a professional and in-depth survey on the current state of the Synthetic Stem Cells Market. The report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Synthetic Stem Cells Market analysis is provided for the international market including development history, competitive landscape analysis, and major regions' development status.

The synthetic stem cells market is anticipated to increase in the market owing to the risk of tumor formation in stem cell and immune rejection of natural stem cells. However, the unclear and unregulated regulations on the use of synthetic stem cells can restrain the growth of the market. Moreover, the increase in funding in research for the stem cell is propelling the market in the forecast period.

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Leading Players in the Synthetic Stem Cells Market:FiservNucleus SoftwareNewgen SoftwareSigma InfosolutionsCU DirectFIS GlobalRoostifyHiEnd Systems

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Synthetic Stem Cells Market 2020 Recent Industry Developments, SWOT Analysis, Important on COVID 19 Outbreak, Growth Strategies Adopted by Top Key...

VIRGINIA BEACH, Va., Dec. 29, 2020 /PRNewswire/ --ViviGenCellular Bone Matrix the first cellular allograft to recover and protect viable, lineage-committed bone cells supports outcomes that are comparable to autograft and superior to a conventional mesenchymal stem cell (MSC)-based cellular allograft in even high-risk foot and ankle procedures, according to two recent peer-reviewed publications.

A retrospective analysis of 135 high-risk foot and ankle procedures published in the journal Foot & Ankle Specialist showed that ViviGen supports fusion even in patients with comorbidities that create higher risk of nonunion, such as diabetes, thyroid disease and alcohol abuse. The overall fusion rate across two high-risk patient groups 113 undergoing arthrodesis and 22 undergoing open reduction internal fixation (ORIF) was 86 percent, which is comparable to fusion procedures using autograft while avoiding the challenges associated with autograft recovery. There also was no statistical difference in the fusion rate between primary and revision procedures.

"By providing osteogenic cells in an osteoconductive and osteoinductive matrix, ViviGen helps maximize bone healing, even for revision cases, diabetics, and smokers," said Joseph Park, MD, one of the authors of the study, which was performed at the University of Virginia Health System in Charlottesville, Va.

A second retrospective study, published in Clinical Research on Foot & Ankle,showed that ViviGen outperformed a leading MSC-based graft in both clinical and patient-reported outcomes following foot and ankle fusions. The study involved 47 consecutive cases, with 31 patients receiving ViviGen and 16 receiving the MSC graft. The ViviGen patients experienced fusion at double the rate of the MSC patients including among patients with comorbidities such as diabetes and tobacco use experienced fewer complications and reported lower post-operative pain.

These results reinforce that viable, lineage-committed bone cells, such as those in ViviGen, may better support bone fusion than MSCs and demonstrate that ViviGen can lead to successful clinical and patient-reported outcomes with minimal complications in foot and ankle surgery.

"These studies are an exciting advancement of our knowledge of ViviGen," said Mark Moore, PhD, Chief Scientific Affairs Officer at LifeNet Health. "We developed ViviGen based on pre-clinical research that showed a cellular graft focused on viable, lineage-committed bone cells could result in a safe, clinically effective bone void filler. These clinical results further support that conclusion, especially in comparison to first generation cellular grafts that focus on undifferentiated MSCs."

About LifeNet HealthLifeNet Health helps save lives, restore health, and give hope to thousands each year. It is the world's most trusted provider of transplant solutions from organ procurement to bio-implants and cellular therapies and a leader in regenerative medicine, while always honoring the donors and healthcare professionals who enable healing. For more information about LifeNet Health, go to http://www.lifenethealth.org.

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http://www.LifeNetHealth.org

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ViviGen Cellular Bone Matrix outperforms MSC-based allografts and is equivalent to gold standard autograft - PRNewswire

A NURSERY teacher who had to remortgage her home to fund a gruelling four-week treatment programme in Mexico has made it back home.

Nina Matthews, 42, was diagnosed with multiple sclerosis (MS) in 2009 after going temporarily blind with optic neuritis, and collapsing in a shop.

Her condition has deteriorated over the years, forcing her to stop working, and even facing the prospect of being bed-bound within the next six months.

The 28 day course of haematopoietic stem cell therapy (HSCT) should prevent her condition from progressing if it's successful, allowing her to regain mobility and hopefully return to work.

Mrs Matthews said: "It was brutal, probably worse than I expected I'm just doing a lot of sleeping.

"I feel better now I've had it but it's going to take a long time to see results, although I am noticing minor improvements.

"Apparently recovery is like a rollercoaster and then after about two years you see continuous improvement if the treatment works.

"My prognosis was really not good at all, and the deterioration was significant at least what ever I do to try and help myself won't be in vain and be undone now. I can just focus on improving."

The treatment at Clinica Ruiz consisted of four rounds of chemotherapy, before stem cells were harvested and then reinserted into the body.

Although the treatment is available in the UK for people who meet a certain criteria, Mrs Matthews was not eligible, and had to pay 45,000 to cover the

Her medication, which costs 70,000 a year, is available through the NHS, but this only manages her symptoms and does not prevent the disease from progressing further.

HSCT is typically used to treat bone marrow and blood cancers, but has also shown effectiveness in treating MS, according to the MS Society.

There is currently no cure for the disease.

Coronavirus has disrupted the treatment, cancelling their original flights and making recovery difficult.

Mrs Matthews added: "I now have the immune system of a newborn baby - for the next six months I'll be staying inside.

"Obviously with the current situation I've got to be extra careful.

When I booked it covid wasnt even an issue and obviously a lot of our fundraisers had to be cancelled.

"We've had to remortgage the house and it's a new kind of stress now, we need to continue to maintain some kind of quality of life, especially whilst I can't work."

Just a few weeks before the couple jetted off to Mexico, they were told that their flights had been cancelled due to the pandemic, with a new pair of flights adding 3,500 to the total.

Mrs Matthews appeared on BBC Radio Manchester, where presenter Mike Sweeney appealed for the family to be refunded the extra cost generating enough donations to cover the additional expense.

Raising enough money has been a battle due to the current coronavirus restrictions, with the pair managing to raise just 7,000 towards their goal before setting off.

Mrs Matthews said: "We're relying quite heavily on GoFundMe which has quite understandable slowed down with Christmas and covid, but every donation is appreciated.

"It's ruined us financially but we've been there, done the treatment, and it wasn't good at all but now we can focus on the future.

"I just want to get back to work, being a nursery teacher is all I've ever known and any other small goals will be fantastic to achieve, but I just want to get back to the kids."

Visit justgiving.com/crowdfunding/nina-matthews to help fundraise.

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Horwich nursery teacher finishes HSCT treatment for MS in Mexico - The Bolton News

Researchers discuss the development and potential of stem cellbased therapies in the treatment of Parkinson disease.

In assessing treatment for Parkinson disease (PD), the current standard of care involves levodopa, potentially in combination with carbidopa, to address the loss of dopamine known to occur as the condition progresses. However, several innovations in therapy for PD have occurred in recent years, particularly deep brain stimulation and the potential use of stem cells.

Discussing in a review published in International Journal of Molecular Sciences, researchers Zhaohui Liu, PhD, MSc, and Hoi-Hung Cheung, PhD, sought to discuss the development of new therapeutic strategies that have led to the initiation of exploratory clinical trials, particularly the application of stem cells for the treatment of PD.

Delving into the use of stem cellbased treatments in PD, the researchers say that several important pathways have emerged as targets for potential therapeutic intervention.

Conventional therapeutic strategies for relieving the symptomatic stages of PD remain, but with new genetic insights, it may be possible to use preventive neuroprotective treatments for people at risk of developing PD, they highlight. In parallel with efforts to prevent and control symptomatic PD, researchers are also investigating stem cells as replacements for diseased neurons or degenerated tissues.

As they note, dopaminergic (DA) cell transplantation is believed to be the most promising cell replacement therapy. Aligned with this approach, a recent novel treatment showcased the plausibility of reprogramming the skin cells of a single patient with PD to take on the characteristics of DA neurons and replace damaged brain cells. In their findings, the patient exhibited improvements in quality of life and day-to-day activities requiring motor skills. However, as this treatment was performed on only 1 person, the researchers cautioned that larger, diverse clinical studies are needed to demonstrate further efficacy and long-term results.

Other notable stem cellbased treatments include:

Although we are not yet examining a disease-modifying treatment, stem cell transplantation has the potential to be at the forefront of such PD treatments in the future, conclude the researchers. The transplantation process and the procedures required for its optimization are still not fully understood, and further research is required to achieve treatment for PD.

Reference

Liu Z, Cheung H-H. Stem cell-based therapies for Parkinson disease. Int J Mol Sci. Published online October 29, 2020. doi:10.3390/ijms21218060

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A Review of Stem CellBased Therapies for Parkinson Disease - AJMC.com Managed Markets Network

By The Acorn Staff | on November 05, 2020

Twenty years ago, when stem cell therapy was highly regulated in the United States and other countries, it was well underway in the Hadassah Hospital labs in Jerusalem.

Never would we have imagined that the U.S. expansion of one of the key clinical trials conducted in our labs in Israel would be later funded by Californias Stem Cell Institute.

In 2004, California had the foresight to advance this critical area of research with the passage of Prop. 71 in 2004.

Stem cells replace damaged or diseased tissue. In this way, treatments or cures for diseases like age-related macular degeneration, ALS, MS, Parkinsons, Alzheimers and diabetes could be a reality in the foreseeable future.

I come to this subject from a place of personal sorrow. I watched my father-in-law, Irv, suffer for 12 years with ALS, a man I loved as if he were my own father. He fought hard. He made every minute of his battle meaningful, to soak up as much life as he could until he couldnt.

Hadassah researchers conducted the worlds first clinical trial using the patients own bone marrow stem cells to treat ALS. Expanded stem cell trials are now taking place here in California to treat ALS.

The California Stem Cell Agencys ALS funding has awarded a total of $79 million in grants to understand ALS and then to translate those discoveries into treatments and therapies. Two have already reached the clinical trial phase.

A Phase 1 clinical trial at Cedars-Sinai was funded to investigate the safety and efficacy of ways in which surviving neurons can be protected in people with ALS.

The second, a Phase 3 clinical trial at Brainstorm Cell Therapeutics, first began in Israel. The approach is to use mesenchymal stem cells derived from bone marrow boosted with protective factors to support and protect the neurons of ALS patients.

Stacey DorenfeldAgoura Hills

Dorenfeld is the National State Advocacy co-chair and the Hadassah Southern California advocacy chair.

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Stem cells key to ALS therapy - Agoura Hills Acorn

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Stem Cell Res. 2020 Oct 15;49:102030. doi: 10.1016/j.scr.2020.102030. Online ahead of print.

ABSTRACT

Multiple myeloma (MM) is a hematological cancer characterized by an uncontrolled proliferation of antibody-secreting plasma cells within the bone marrow. Currently, cell therapy such as chimeric antigen receptor T-cell (CAR-T) based on induced pluripotent stem cells (iPSCs) has received attention for treating MM. However, the generation of iPSCs from MM patients appears to be very rarely reported. Here we generated an iPSC line from CD34+ bone marrow cells of a patient with MM using human placenta-derived cell conditioned medium (hPCCM), offering a relatively high efficiency in humanized conditions. This iPSC line might be a useful model for research on MM.

PMID:33142253 | DOI:10.1016/j.scr.2020.102030

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Generation of normal induced pluripotent stem cell line KUMCi002-A from bone marrow CD34+ cells of patient with multiple myeloma disease having 13q...

Human Embryonic Stem Cells (HESC) Market Size And Forecast

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Human Embryonic Stem Cells (HESC) Market Segmentation:

Human Embryonic Stem Cells (HESC) Market Segment by Type:

Human Embryonic Stem Cells (HESC) Market Segment by Application:

Human Embryonic Stem Cells (HESC) Market Segment by Global Presence:

North America Latin America Middle East Asia-Pacific Africa Europe

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Human Embryonic Stem Cells (HESC) Market 2020 Manufacturer Analysis, Emerging Trends, Top Companies and Forecast to 2027 - TechnoWeekly

The Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market study describes the current market size and market forecast, market prospects, main drivers and constraints, regulatory scenario, industry trend, PESTLE analysis, PORTER analysis, new product approvals / launch, promotion and marketing campaigns, pricing analysis , competitive environment to assist companies in decision-making. The data from the study is focused on current and historical market dynamics that assist in decisions related to investment.

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Global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market Overview With Detailed Analysis, Competitive Landscape, Emerging Trends ,...

The Alexander Grass Humanities Institute (AGHI), in conjunction with Great Talk, Inc., hosted a panel of scientists to speak about the ethical considerations and implications of stem cell research on Oct. 21.

The event was moderated by Director of AGHI William Egginton. The four panelists included two experts in genomics research, a journalist who specializes in the role of technology in biomedical research and an expert in medical law.

Dr. Anthony Wynshaw-Boris, chair of the Department of Genetics and Genome Sciences at Case Western Reserve University School of Medicine, discussed how cell lines were cultivated as tools in the past for scientists to use to grow cell cultures to study diseases or develop vaccines. However, there wasnt as much debate about the development of these tools in the past as there is now.

These are scientific tools that we use. The political and social aspects... are arising today because of our polarization, Wynshaw-Boris said.

The panel had an in-depth conversation regarding the ethics of the use of scientific tools such as stem cell lines derived from fetal tissue, embryonic cells, abortion-derived cell lines and cells acquired without consent.

Dr. Eric Green, director of the National Human Genome Research Institute at the National Institutes of Health, argued that the investment that has been made in these cell lines to calibrate them for use in biomedical research cannot be ignored.

Should there be a halt on the use of that mature tool because of its origins that were created in a time when there was a different view? Green asked.

Antonio Regalado, senior editor for biomedicine at MIT Technology Review who writes about the impact of technology on medicine and biomedical research, responded to Greens query.

Regalado brought up the fact that makeup companies have been facing a lot of backlash recently for testing their products on animals. Regalado pointed out that makeup companies could then use a similar argument by saying that since they have already invested money in animal testing procedures, they should not have to find new, less harmful methods of testing.

I don't know that we should rule out the possibility of alternatives if the scientific community decides to put their minds to it. Perhaps an equivalent cell line could be developed, Regalado said.

Diane Hoffman, director of the Law and Health Care Program at the University of Maryland Francis King Carey School of Law, described various perspectives in debate over the ethical concerns of stem cell research.

The challenge, according to Hoffman, is striking a balance between implementing a blanket policy through the government and informing consumers to allow them to make ethical decisions.

Industry wanting innovation, and government wanting safety and efficacy, and consumers wanting access. Those three things are... how we consider these ethical issues, Hoffmann said.

The conversation then shifted to eugenics, the practice of editing human DNA to achieve specific, desirable characteristics, such as eliminating diseases, changing eye color or editing IQ.

Green described an initiative funded by the Human Genome Project, the Ethical, Legal and Social Implications Research Program (ELSI), which focuses on the ethical, legal and social implications of biomedical research.

We can meld together what is scientifically possible to what is the body of evidence of what has come out when we have looked at these ELSI issues and then have conversations... and try to come to consensus on what the guardrails should look like, Green said.

Hoffmann echoed Green, describing the need of the scientific community to also consider allocation of these resources.

Weve got a ways to go in terms of thinking about... how we can be more just in our allocation of medical resources and the benefits of the research were doing, Hoffmann said.

She brought up the idea of giving priority in receiving benefits to vulnerable populations that have been previously harmed by the health-care system.

Wynshaw-Boris added that each study that is conducted needs to address the ELSI considerations mentioned by Green.

Studies have to be done... in partnership with diverse populations, and we have to be committed to that, Wynshaw-Boris said. We have to make progress on it all the time, and that's what we have to be committed to.

The discussion concluded with a consensus among the panelists that the scientific community needs to address social and health inequities as advancements in genetics and genomic techniques continue to occur.

We have to bring more trust to science than exists now, Green said.

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Panelists debate the implications and ethics of stem cell research - Johns Hopkins News-Letter