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Category Archives: Stem Cell Therapy

Tweet Chat Recap: Evaluating Treatment Approaches for Relapsed/Refractory DLBCL – Targeted Oncology

Posted: September 12, 2020 at 9:54 pm

Targeted Oncology was joined by Kami J. Maddocks, MD, associate professor of clinical internal medicine, Division of Hematology, The Ohio State University Comprehensive Cancer CenterJames, for the discussion of a 76-year-old man with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in a recent tweet chat. In this case scenario, the patient presented with stage IV high-risk disease and received R-CHOP (Rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, prednisone), and radiotherapy.

Although the treatment appeared well-tolerated, the patient presented with similar symptoms as at diagnosis after completing 6 cycles with complete response to the therapy. According to the work-up, the patient is ineligible for transplant.

The patient was ineligible for stem cell transplantation (SCT), which Maddocks speculates may be due to the patients age, although other considerations could include comorbidities or intolerance to R-CHOP. Eligibility is the first thing she considers for her patients as it is currently the standard of care and the only curative approach for patients to receive salvage chemotherapy followed by consolidation with autologous SCT.

Maddocks told Targeted Oncology, In some patient cases, [the reason for ineligibility] is age even though there's no specific age cutoff, but we know that it's harder on the marrow as patients get older to collect stem cells and get that aggressive salvage chemotherapy. Patient comorbidities [can also impact eligibility], so heart conditions, lung conditions, renal insufficiency can be a problem. Performance status and then lastly, just if the patient had trouble getting to their initial chemotherapy with R-CHOP or had a lot of complications, then it's probably going to be harder for them to tolerate even more aggressive or intensive therapy.

In a twitter poll ahead of the chat, Targeted Oncology asked what the next best line of therapy for this patient might be, with 4 potential different treatment options. The option that drew the most attention, however, was the recently approved regimen of tafasitamab (Monjuvi) and lenalidomide (Revlimid).

Maddocks tweeted, All these options are potential therapeutic choices for this patient, but the combination of tafasitamab/lenalidomide is the only option approved in this setting. The treatment has a promising ORR [overall response rate], and CR [complete response], and the remissions for patients who respond are durable!

During the tweet chat, Maddocks reviewed each of the different treatment options in the poll, and why she selected this combination regimen as the next best line of therapy for this particular patient. Following the chat, she spoke with Targeted Oncology to share further insights on each of these therapeutic approaches and the importance of the FDAs approval of tafasitamab plus lenalidomide in this setting.

The combination of tafasitamab plus lenalidomide held the majority vote, which Maddocks agreed would be the next best line of therapy for this patient.

For patients who are not candidates or considered eligible for a salvage chemotherapy followed by autologous SCT, the tafasitamab/lenalidomide combination was recently approved in the setting of first relapse, and it's the only approved therapy in this setting, Maddocks said. Historically, we would give some sort of palliative chemotherapy approach if patients were candidates and interested in pursuing therapy, or consideration of clinical trial, but this is the only therapy approved in this setting.

The approval of tafasitamab in combination with lenalidomide includes an indication for patients who are not eligible for autologous SCT, as describes the patient in our case. This regimen was approved on the basis of the phase 2 L-MIND (NCT02399085) clinical trial, which explored this use of this regimen in 81 patients with relapsed/refractory DLBCL. Two-year follow-up demonstrated an ORR of 58.5%, which included CRs in 41.3% of patients and partial responses (PRs) in 17.5% of patients. In addition, 15.0% achieved stable disease, and the median duration of response was 34.6 months (95% CI, 26.1-34.6).1

I think this patient case is the perfect example of where this can fit into the treatment landscape, Maddocks explained. For patients who first relapse from the standard R-CHOP therapy, the toxicities were generally manageable, and with the response rate, this is a great option for patients at first relapse who are not going to be candidates for a transplant. I think maybe patients who go on to get palliative chemotherapy or maybe patients who get treatment with plans to go to transplant but just don't tolerate it and dont look like they're going to [undergo] aggressive therapy, this may be an option for those patients too, understanding that there is some role for CAR T in a set of those patients.

This study, which was presented during the 25th Congress of the European Hematology Association (EHA), demonstrated that the majority of toxicities were hematologic, and most were reversible. The most common grade 3 hematologic treatment-emergent adverse events (TEAEs) were neutropenia in 49.4% of patients, thrombocytopenia in 17.3%, and febrile neutropenia in 13.2%.1

These were able to be managed by holding the dose growth factor, and there was a population of patients who had to be dose-reduced on the lenalidomide. The starting dose was 25 mg, so the majority were able to maintain 20 mg if they were dose-reduced, although a few had to be reduced more than once, Maddocks said. The most common grade 3/4 or serious AEs were infection, probably not surprisingly, and overall, that's probably similar to what you see with other options in this setting. There was a small number of infusion reactions, but these were all grade 1 in the trial and were easily managed.

Non-hematologic TEAEs of grade 3 included pneumonia in 8.6% of patients and hypokalemia in 6.2%. Serious AEs reported included pneumonia in 8.6%, febrile neutropenia in 6.2%, and pulmonary embolism in 3.7%, as well as bronchitis, lower respiratory tract infection, atrial fibrillation, and congestive cardiac failure in 2.5% each.1

Given the safety profile of this combination of tafasitamab plus lenalidomide, this regimen is particularly suitable for a large proportion of patients with DLBCL, Gilles Salles, MD, PhD, lead author of L-MIND, toldTargeted Oncology. We do know that the median age of occurrence of DLBCL is in the late 60s, and there are many, many patients that are over 70 and that are not usually transplant eligible. Clearly this is a great opportunity for patients to receive this non-cytotoxic regimen.

Although this regimen is an exciting opportunity for patients with DLBCL and relapsed/refractory disease, 1 challenge that needs to be addressed is the potential use of tafasitamab plus lenalidomide in sequence with CAR T-cell therapy. There is very little experience, if any, of patients receiving the combination regimen after receiving CAR T-cell therapy. The combination and CAR T cells both target the same antigen, CD19, which can be problematic. As its known that some patients will lose CD19 expression on CAR T-cell therapy, the regimen may no longer be an effective treatment option.

For those patients that had failed CAR T-cell therapy, substantial proportions, about 30% of them, may have lost CD19 expression and then may not be eligible anymore for this regimen. There is, however, a substantial proportion of patients that retains CD19 and in whom tafasitamab/lenalidomide can be used as a treatment option, Salles commented.

A large proportion of patients will maintain CD19 expression following CAR T-cell therapy, so tafasitamab plus lenalidomide may still be effective in a percentage of patients.

Its hard to say because we dont have a lot of data, but we do know there are other CD19-directed therapies outside of CAR T cell development, Maddocks told Targeted Oncology. I think in the next few years, were going to see patients treated both pre- and post-CAR T with other CD19-directed therapies, and well have more information on this.

The combination of polatuzumab vedotin (Polivy) plus bendamustine (Bendeka) and rituximab (BR) was approved by the FDA as treatment of patients with relapsed/refractory DLBCL after 2 prior lines of therapy in June 2019 based on the findings from the phase 1b/2 GO29365 (NCT02257567) clinical trial. Although this option is also not FDA-approved for the treatment of patients after first relapse, Maddocks noted that this was the only treatment evaluated in a randomized trial. The study had included patients who were ineligible for transplant.

Significant improvements were observed with polatuzumab vedotin plus BR compared with BR alone in an international, multicenter, open-label study, particularly in regard to the ORR, CRs, progression-free survival (PFS), and overall survival (OS). CRs were observed in 40.0% of the patients with the combination versus 17.5% with BR alone. Survival rates favored the combination as well, with a median PFS of 9.5 months with the combination versus 3.7 months with BR alone (HR, 0.36; 95% CI, 0.21-0.63; P <.001) and a median OS of 12.4 months versus 4.7 months (HR, 0.42; 95% CI, 0.24-0.75; P =.002), respectively.2

The addition of polatuzumab did increase toxicity from the standpoint of cytopenias, but that didn't really translate to increased serious infections. It did add neuropathy as a side effect, but most of that was reversible, so I think this was a regimen that, by the addition of polatuzumab, was something that you could offer patients that did give them somewhat of a better overall response and was more durable than just giving them a palliative chemotherapy alone, Maddocks added. This is also a regimen that's been used in patients who were not able to achieve a remission to bridge them to CAR T or in some patients after CAR T, and so I can understand why this was definitely one of the more favorable choices.

In the study, grade 3/4 neutropenia was observed more frequently in the combination arm (42.6%) compared with the BR alone arm (33.3%), but the occurrence of grade 3/4 infections was comparable between the 2 groups (23.1% vs. 20.5%, respectively). In addition, the study authors noted that although many of the fatal AEs occurred after disease progression, 11 patients in the BR arm experienced fatal AEs compared with 9 in the combination arm, infection being the most common, which was the cause in 4 patients in each arm.2

Although the regimen appeared tolerable in this setting, Maddocks tweeted, it is more attractive than chemotherapy alone and understandable why it was chosen [as the second-best option in the Twitter poll].

Among the treatment options considered in our twitter poll ahead of the tweet chat, selinexor (Xpovio) only caught the attention of 16.7% of voters, similar to CAR T-cell therapy. However, both of these options are currently only approved in patients who have received at least 2 prior lines of therapy, which this case did not.

In regard to selinexor in particular, Maddocks tweeted, Looking at the single arm phase 2 data, it also has the lowest overall response rates of all the options listed with an ORR of 28%.

Selinexor received its approval from the FDA in June 2020, which is indicated for the treatment of adult patients with relapsed/refractory DLBCL, not otherwise specified, who have received at least 2 prior systemic therapies. This is the only oral single-agent therapy approved in this setting, and it is also the only nuclear export inhibitor approved by the FDA for use in hematologic malignancies.

The agent was approved on the basis of the phase 2b SADAL clinical trial, which demonstrated an ORR of 29% with 13% CRs and 16% PRs. The responses achieved in the study were durable, which led to a median duration of response of 9.2 months in the overall population (95% CI, 4.8-23.0) and 13.5 months in those who had achieved a CR (95% CI, 9.3-23.0).3

The most common treatment-related AEs were cytopenias and gastrointestinal/constitutional symptoms, which were generally reversible and manageable with dose modifications and/or standard supportive care approaches. The most common on-hematologic AEs, which were mostly grade 1/2, were nausea (52.8%), fatigue (37.8%), and anorexia (34.6%). The most common grade 3/4 AEs included thrombocytopenia (39.4%), neutropenia (20.5%), and anemia (13.4%). No treatment-related grade 5 AEs were observed.

CAR T-cell therapy, on the other hand, offers a unique option to this patient case even though it is still only approved in patients who have progressed or relapsed after 2 prior therapies or SCT. The TRANSCEND-PILOT-017006 (NCT03483103) study is evaluating the potential for CAR T-cell therapy lisocabtagene maraleucel (liso-cel) as treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma who have received at least 1 prior therapy and are ineligible for SCT. While this does appear promising for introducing CAR T-cell therapy earlier on for patients with DLBCL, the treatment is not available off trial and is not a standard approach.

Maddocks told Targeted Oncology, It's very clear who's eligible for autologous transplant by age and comorbidities, but with CAR T, it's not so clear all the time who is going to be a candidate. There's not as great of data or information on who is going to be a candidate for that or not. Probably more patients are going to be a candidate for transplant, but there is still going to be patients that are comorbidities that they're not going to be a candidate for CAR T cells, and while they're approved in this setting and they can be very effective, there's also logistical issues, including that right now there's only certain centers, most often transplant centers, that are able to administer CAR T cells, so the patient has to have access to a center, they have to be able to get through the time that their leukapheresis cells are sent out and then sent back, and there's still barriers to cost and insurance in some patients, too.

This particular patient case does represent a challenge, Maddocks said. Historically, this is not a patient that's going to be a candidate for an autologous SCT, and that's going to be the only curative approach. CAR T is not approved in this setting, which is the other curative approach we know outside of patients who are unable to get to autologous STC, or at least appears to be likely curative for a percentage of patients.

Overall, CAR T-cell therapy is not a viable treatment option for the patient depicted in our tweet chat discussion, although it can still offer curative opportunities to a select group of patients with DLBCL who are ineligible for transplant.

In conclusion, tafasitamab plus lenalidomide helps fulfill the unmet need of patients who are in first relapse but are ineligible for transplant, which is the only curative option for patients with relapsed/refractory DLBCL. Although CAR T cells appear hopeful in this space, more research needs to be done to further determine their role in the treatment paradigm.

When you look at relapsed DLBCL, in general, and have these options, it's exciting for our patients to be able to have these. All of these have come up in the last 1 to 2 years, CAR T being a little bit longer than the other 3 regimens, but they all have offered patients tolerable therapy in the setting of previously not having these options.

Reference

1. Salles G, Duell J, Gonzlez-Barca E, et al. Long-term outcomes from the phase II L-MIND study of Tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Presented at: Presented at: EHA25 Virtual; June 11-21, 2020. Abstract EP1201.

2. Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.J Clin Oncol. 2019;38(2):155-165. doi: 10.1200/JCO.19.00172

3. Kalakonda N, Cavallo F, Follows G, et al. A phase 2b study of selinexor in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).Hematol Oncol. 2019;37(S2). doi: 10.1002/hon.31_2629

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COVID-19 Pandemic Impact on Global Stem Cell Therapy Market 2020-2024 | Technavio – Business Wire

Posted: August 26, 2020 at 8:00 pm

LONDON--(BUSINESS WIRE)--The stem cell therapy market is expected to register a CAGR of almost 7% during 2020-2024, as per the latest research report by Technavio. The report offers a detailed analysis of the impact of COVID-19 pandemic on the market in optimistic, probable, and pessimistic forecast scenarios.

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Due to the extensive spread of the virus across the globe, the Health Care Industry is anticipated to have Positive impact. The stem cell therapy market will showcase Neutral impact during 2020-2024.

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Stem Cell Therapy Market is segmented as below:

North America region will account for the highest incremental growth during the forecast period due to the high number of research facilities and government funding for innovative stem cell and regenerative medicine research.

With the surging growth of COVID-19 pandemic, the Health Care market is anticipated to have a Direct impact during the forecast period. View market snapshot before purchasing

Limited number of FDA-approved stem cell therapies has been an instrumental factor in influencing the growth of stem cell therapy market. Other market drivers include accelerated regulatory approval. Technavio offers custom research analysis on the crucial pointers to highlight the impact of COVID-19 on the market across the supply chain.

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Stem Cell Therapy Market 2020-2024: Vendor Analysis

The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Key players in the market have been launching several initiatives and introducing innovative products and services to cater to a larger target audience during the pandemic. Major market participants include Gilead Sciences Inc., Holostem Terapie Avanzate Srl, Lineage Cell Therapeutics Inc., Lonza Group Ltd., Novartis AG, Nuvasive Inc., Organogenesis Inc., Osiris Therapeutics Inc., RTI Surgical Holdings Inc., and Vericel Corp.

Technavio's custom research reports offer detailed insights on the impact of COVID-19 at an industry level, a regional level, and subsequent supply chain operations. This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations. Register for a free trial today and gain instant access to 17,000+ market research reports. Technavio's SUBSCRIPTION platform

Table of Contents:

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Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

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ProgenCell – Stem Cell Therapies announces new facilities – PR Web

Posted: August 26, 2020 at 8:00 pm

Our patients will have access to even more services and extraordinary specialists available at the medical tourism complex, in a convenient and strategic location.

SAN DIEGO (PRWEB) August 25, 2020

ProgenCell - Stem Cell Therapies is announcing the opening of its brand new Stem Cell Treatment Center to give international and local patients a more comprehensive medical treatment in a luxury and stress free environment. With this announcement, ProgenCell establishes its leadership in the field of regenerative medicine and medical tourism. ProgenCells New Clinic is part of the one of a kind all-in-house medical tourism complex: NewCity Medical Plaza.

A great deal of planning went into making this stem cell treatment right for the wide range of medical conditions we deal with, said Dr Jorge Gavino, president of ProgenCell Scientific Committee. Our patients will have access to even more services and extraordinary specialists available at the medical tourism complex, in a convenient and strategic location. Im excited to welcome patients at this new facility.

It has been a long journey. Time had given lot of experience since 2008, when the clinic was found, said Elias Bemaras, CEO. Stem cell therapy has evolved, has improved in many ways, getting better results, learning from long term treated patients. We understand the need for a new facility, more convenient for patients with equipment renovation, better distribution, and a better location. Although a high investment is required, we believe it is worth it because our patients will receive better service, easier logistics, more time with the doctor, better follow up, and that translates to 360 degrees patient satisfaction.

With this new facility, ProgenCell establishes its commitment to offer the most advanced technology in modern and comfortable facilities and in a fully licensed, government regulated and certified facility, overseen by an independent ethics and scientific committee.

About ProgenCell - Stem Cell TherapiesProgenCell - Stem Cell Therapies is a leading stem cell treatmentcenter that offers individualized stem cell therapies for patients with chronic-degenerative diseases with more than 10 years of experience. ProgenCell also provides assistance with lodging, traveling and logistics to provide a comprehensive and safe medical tourism experience.ProgenCell is now part of the Health System of NewCity Medical Plaza, a modern and innovative Medical Tourism Center in Tijuana, Mexico. NewCity Medical Plaza is a 30-story tower, with doctors offices, hospital, medical lab, imaging center, commercial plaza, gastronomic center and a 140-room five star hotel.

To learn more about ProgenCell new facilities or scheduling inquiries contact ProgenCell directly at 1 888 443 6235 or email info@progencell.com

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Animal Stem Cell Therapy Market 2020 | Global (North America, Europe, Middle East & Africa, Latin America and the Asia Pacific) Market Status and…

Posted: August 26, 2020 at 8:00 pm

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Animal Stem Cell Therapy Market 2020 | Global (North America, Europe, Middle East & Africa, Latin America and the Asia Pacific) Market Status and...

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The Road To Scale: Challenges Facing the Implementation of Animal-Free Recombinant Proteins Into Stem Cell Supply Chains – Technology Networks

Posted: August 26, 2020 at 8:00 pm

Most industries today are under pressure to switch to more ethical and sustainable animal-free alternatives, and now the trend is coming to stem cell labs. As stem cell applications accelerate towards the clinic, novel drug discovery platforms are rapidly scaled, and new transformative stem cell-based technologies such as cultured meat arise, there is a drive to switch to animal-free cell culture media. This move is essential to facilitate future regulatory approval for advanced therapies, and enable pharma and biotech companies to ethically, reproducibly and cost-effectively scale stem cell-based innovations.Most stem cell scientists today use recombinant growth factor and cytokine proteins in their chemically-defined media to supply their cultures with the necessary biological signals required for maintenance of pluripotency, cell proliferation and differentiation into specific cell lineages. However, the fundamental biochemistry and manufacturing processes of these protein messengers can often be overlooked. But as scientists are trying to establish new animal-free systems to support the scale-up of their stem cell applications, the properties and challenges inherent in these proteins are becoming more prominent and frankly a headache for many.

Highlighted here are three key challenges facing pharma and biotech companies as they embark on the path to implementing animal-free systems, from the perspective of two protein scientists.1.Why batch consistency is kingAs stem cell therapies gear up to make the leap from bench to clinic and the promise of stem cell biology in drug discovery and other industrial applications is realized, more subtle and still largely inexplicable challenges in optimizing growth factor and cytokine supply chains for defined media are being identified why when you change from one supplier or even batch of a recombinant protein do stem cells need weaning onto that protein, or dont tolerate the change? Is this a fundamental lack of batch consistency across the supply chain or is there an underlying biological basis?

At the minute, there is simply not enough data to answer this definitively. While we are starting to tease apart these questions, it highlights the need for greater innovation within the recombinant protein supply chain to bring best practice and innovation from other areas to improve the robustness of the global supply chain and encourage great openness and scrutiny of fundamental biochemical quality early in process development.

Questions we should ask include: are we seeing heterogeneity in post-translational modifications, which is well documented in monoclonal antibody manufacturing? Can synthetic biology or protein engineering be used to optimize proteins and engineer out features contributing to this variation?

For now, and until we have answers, its a good idea to source proteins from reputable suppliers that have rigorous standards for batch quality testing and meticulously scrutinize all biochemical and bioactivity data provided.2.Cost of goods as a barrier to scaleTo bring innovative stem cell applications to market, pharma and biotech companies need to be able to seamlessly scale their cultures, meet regulatory requirements and achieve a sensible and sustainable process cost. Where recombinant proteins are needed in cell culture media, they are usually the greatest contributor to cost of goods.

Well-defined industry challenges catalyze change and the stem cell field is seeing renewed focus on much needed innovation in complex bioactive protein production to meet the needs for animal-free, highly reproducible proteins. Protein engineering technology, enhanced cell-based and cell-free expression systems, such as bacteria, yeast and even plants, coupled with improvements to downstream processing systems are just some of the latest innovations in this space. Previously, there have been concerns over the ability of simpler systems to form correctly folded and bioactive recombinant proteins. However, it is clear that many of these barriers can be overcome to produce highly pure growth factors and cytokines at scale.Others are striping back chemically-defined media protocols to determine the essential growth factors and cytokines needed for their cell type. For example, homebrews of key growth factors to reduce costs - Paul Burridge and his team at Northwestern University Feinberg School of Medicine have pioneered a cost-effective B8 chemically-defined media for weekend-free hiPSC culture at just 3% of the price of commercially available media. Now the challenge is to take the learnings from academic studies such as these and translate them into industrial processes.Meating the price of lab-grown steaksYou cannot discuss the cost of growth factors without mentioning the daunting step-change and barrier facing the fast-evolving cultured meat market. Here, highly optimized animal-free growth factor production systems will be required to provide the economies of scale needed to deliver kilogram-ton quantities at a fraction of the price in order to bring these lab-grown meat alternatives to consumers. After all, it just isnt viable for companies to be spending hundreds of dollars on each liter of culture media - instead, this needs to be reduced to ~$1/liter.3.Animal-free or ADCF? Now that is the questionDespite animal-free/animal-derived component free (ADCF) growth factors and cytokines becoming increasing important, there are no standard definitions for these terms across the industry, with many protein manufacturers supporting the sector by defining their own internal standards. For the clinical space, the United States Pharmacopeia and International Organization for Standardization have published a framework for classifying raw materials used in cell therapy manufactureinto four different tiers based on their risk. Under this classification, ancillary materials used in the manufacture of cell-based therapies and tissue-engineered products, such as recombinant growth factors and cytokines, are considered low risk so fall into tiers 1 and 2 with an ADCF level of manufacturing defined as all components, sub-components and consumables do not contain materials derived from animals.To support the wider sector, not just those at the transition to the clinic, clarity over definitions and transparency from manufacturers will help to define and overcome the challenges faced and allow the promise of stem-cell derived innovations to be delivered.

Article Authors:

Beata Blaszczyk, Senior Scientist, Qkine

Dr Catherine Elton, CEO and Founder, Qkine

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The Road To Scale: Challenges Facing the Implementation of Animal-Free Recombinant Proteins Into Stem Cell Supply Chains - Technology Networks

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Expression Therapeutics Announces Success in Developing a Stem Cell Lentiviral Gene Therapy for Hemophagocytic Lymphohistiocytosis (HLH) – PRNewswire

Posted: August 26, 2020 at 8:00 pm

ATLANTA, Aug. 24, 2020 /PRNewswire/ -- Primary HLH is a family of devastating primary immune deficiencies with limited treatment options and no gene therapies under clinical testing. Expression Therapeutics has developed a promising and potentially curative gene therapy candidate for familial hemophagocytic lymphohistiocytosis (HLH) type 3 (FHL3). Untreated, FHL3 presents as a hyper-inflammatory state with multi-organ damage leading to premature death. Expression Therapeutics expects to rapidly progress candidates for other common forms of primary HLH as well.

"We are excited to announce this expansion of our gene and cell therapy pipeline beyond our lead stem cell lentiviral gene therapy candidate for hemophilia A that is entering Phase 1 clinical testing. Through ongoing research and development incorporating our core technology platforms, Expression Therapeutics has been able to rapidly generate promising therapeutic candidates for our HLH portfolio and several other critical disease areas with significant unmet clinical need," said Christopher Doering, Ph.D., Chief Scientific Officer of Expression Therapeutics.

Proof of concept for stem cell lentiviral gene therapy of FHL3 was demonstrated using primary patient cells and a genetic mouse model of FHL3. A key component in this success was the integration of one of Expression Therapeutics' core technology platforms that facilitates the rapid generation of transgenes with superior potency. Our lead candidate successfully restored exocytosis and cytolytic function to primary patient cells as well as a murine disease model strongly supporting the advancement of this pipeline product candidate.

"We believe there are three key aspects to FHL3 that make it a strong candidate for hematopoietic stem and progenitor cell (HSPC) lentiviral vector (LV) gene therapy. First, preclinical and clinical studies suggest that less than 20% genetically corrected cells are required to reverse most FHL3 disease symptoms. Second, because of the autologous nature of stem cell-based lentiviral gene therapy, the grave risk of graft vs host disease is eliminated. Third, with stem cell-based lentiviral gene therapy there will be no wait time to find a sufficiently human leukocyte antigen-matched donor," said Trent Spencer, Ph.D., President of Expression Therapeutics.

According to Deanna Fournier, Executive Director of the Histiocytosis Association, "We are very excited about the possibilities this work offers. Our HLH community, and the entire histiocytosis community, is very hopeful and excited about the future!"

Expression Therapeutics is a biotechnology company based in Atlanta and Cincinnati. The current therapeutic pipeline includes advanced gene therapies for hemophilia, neuroblastoma, T-cell leukemia/lymphoma, acute myeloid leukemia (AML), and primary immunodeficiencies such as hemophagocytic lymphohistiocytosis (HLH).

For inquiries, please contact:

Ashley WalshDirector of Corporate DevelopmentExpression Therapeutics 1860 Montreal RoadTucker, Georgia 30084[emailprotected]+1 312.637.2975www.expressiontherapeutics.com

SOURCE Expression Therapeutics

http://www.expressiontherapeutics.com

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Animal Stem Cell Therapy Market Recent Study Including Growth Factors, Applications, Regional Analysis, and Forecast to 2027 – Scientect

Posted: August 26, 2020 at 8:00 pm

(Augest 2020) SMI published a business research report on Animal Stem Cell Therapy Market: Global Industry Analysis, Size, Share, Growth,Trends, and Forecasts 20202027. Research reportwith 110+ pages on market data Tables, Pie Chat, Graphs & Figures spread through Pages and easy to understand detailed analysis. The information is gathered based on modern floats and requests identified with the administrations and items.

Key players are expected to enhance their marketing capabilities over the forecast period owing to certain market conditions. The report presents certain elements that will reflect whats and hows of such changes in the market. Further, the report studies various aspects of the global market such as upstream raw materials, downstream demand, and production value of leading players subject to market growth.

Download Free Sample Copy of this Report @ https://www.stratagemmarketinsights.com/sample/15082

Geographical segmentation of the Animal Stem Cell Therapy Market involves the regional outlook which further covers the United States, China, Europe, Japan, Southeast Asia and Middle East & Africa. This report categorizes the market based on manufacturers, regions, type and applications.

Animal Stem Cell Therapy Market: Competitive Landscape

Leading players operating in the global Animal Stem Cell Therapy market include Medivet Biologics LLC, VETSTEM BIOPHARMA, J-ARM, U.S. Stem Cell, Inc, VetCell Therapeutics, Celavet Inc., Magellan Stem Cells, Kintaro Cells Power, Animal Stem Care, Animal Cell Therapies, Cell Therapy Sciences, Animacel.

Scope of the Report:

The key features of the Animal Stem Cell Therapy Market report 2020-2027 are the organization, extensive amount of analysis and data from previous and current years as well as forecast data for the next five years. Most of the report is made up of tables, charts, and figures that give our clients a clear picture of the Animal Stem Cell Therapy Market. The structure of the Animal Stem Cell Therapy Market by identifying its various segments and sub-segments to help to understand the report.

Animal Stem Cell Therapy Market is growing at a High CAGR during the forecast period 2020-2026. The increasing interest of the individuals in this industry is the major reason for the expansion of this market.

As the report proceeds further, it covers the analysis of key market participants paired with development plans and policies, production techniques, price structure of the market. The report also identifies the other essential elements such as product overview, supply chain relationship, raw material supply and demand statistics, expected developments, profit and consumption ratio.

Is something restraining your companys growth in the Animal Stem Cell Therapy Market? Ask for the Free sample report here-https://www.stratagemmarketinsights.com/sample/15082

Important Data Available In This Report:

An Overview of the Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms, and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus.

Customer Experience Analysis:

The study offers an in-depth assessment of various customers journeys pertinent to the market and its segments. It offers various customer impressions about products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

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Stem Cell Therapy Market to Show Incredible Growth by 2025 – Scientect

Posted: August 26, 2020 at 7:59 pm

The current report on Stem Cell Therapy Market covers a comprehensive analysis demonstrating actionable insights for clients. In addition, the report offers business insights that encourage them to take suitable decisions which are likely to leverage their business processes. Moreover, the report is a detailed study exhibiting current market trends with an overview of future market study.

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Some of the players in the Stem Cell Therapy market include:

Cytori Therapeutics Inc. (U.S.), Fibrocell Science (U.S.), Cellartis AB (Cellectis) (France), BioTime, Inc. (U.S.), GE Healthcare (U.S.), Thermo Fisher Scientific (U.S.), STEMCELL Technologies Inc. (Canada), Fujifilm Holdings Corporation (Japan), Vericel Corporation (Aastrom Bioscience) (U.S.), Brainstorm cell therapeutics (U.S.), and Osiris Therapeutics, Inc. (U.S.) to name a few.

PrecisionBusinessInsights has recently launched a latest report on Stem Cell Therapy Market for its clients. This report offers the clients with factual data validated by industry experts and business heads. The report highly involves chapter wise explanation for every aspect of the market wherein the drivers, trends, opportunities, leading and trending segments are discussed in detail with specific examples. Profiles of leading players are also discussed along with their business expansion strategies.

An overview of the Stem Cell Therapy Market report offers a comprehensive analysis for better reference to understand market competition and analysis throughout the forecast period. It also involves key players and their market performance and current developments. It helps you understand the technical jargons that offer ease and convenience to you in understanding the report contents.

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Geographical markets are covered separately within the report that includes a competitive analysis on their market performance in the base year as well as predictions for the forecast year. Extensive primary research is conducted to carry out leading information in order to understand the market condition and competition within a specified geography. Comparison between two or multiple geographical markets is carried out effectively to know where to invest in.

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What is the Impact of Covid-19 Outbreak on the Stem Cell Therapy?

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Stem Cell Therapy Market to Show Incredible Growth by 2025 - Scientect

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GoBroad Healthcare Group Showcases Innovative Hematologic Treatment Capabilities at the China Precision Medicine Forum – PRNewswire

Posted: August 26, 2020 at 7:59 pm

40 experts delivered keynote speeches or participated in discussions during the online event, which attracted participants from more than 300 hospitals/institutes and over 40,000 views. Prof. John Gribben, Centre Lead of Haemato-Oncology at Barts Cancer Institute at Queen Mary, University of London, UK and the President of the European Hematology Association (EHA), gave a speech on Advances in Diagnosis and Treatment of Lymphoma in Europe; Prof. Dong Chen, Division of Hematopathology, Department of Laboratory Medicine and Pathology at Mayo Clinic, presented his insights on Integrated Hematopathology Reporting; Prof. Jun Zhu, Director of the Department of Internal Medicine at Beijing Cancer Hospital, who is also the Vice Chairman of GoBroad's Scientific Advisory Board, shares the Current Status and Prospects of the Lymphoma-related Investigational New Drug (IND) in China, etc.

Driven by strong innovation in both research and operation, GoBroad Healthcare Group has created a unique model for specialized treatments in hospitals since its inception in 2017.As of the end of July this year, the healthcare group has conducted over 600 cases of hematopoietic stem cell transplant, registered around 30 clinical trials of Chimeric Antigen Receptor T-Cell Therapy (CAR-T) and undertaken over 1,000 CAR-T treatments. The healthcare group has also published eight academic papers in key hematology journals, includingBloodandLeukemia.

GoBroad Healthcare Group offers advanced services and treatments for the entire range of specialties in hematologic malignancies. Its clinical programs include the discovery and treatment of lymphoma and leukemia in adults and children and a centre dedicated to hematologic and respiratory diseases. GoBroad Medical Institute of Hematology (Beijing Centre) has successfully undertook cutting-edge treatments such as a 23-second allogeneic hematopoietic cell transplant with a survival rate of 88.7%, higher than the global average. GoBroad Medical Institute of Hematology (Guangdong Centre) has adopted the TCR-T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplant to largely reduce GVHD and increase the survival rate. For the first case around the world, the team successfully conducted hematopoietic cell transplant to treat a young patient suffering from Lysinuric Protein Intolerance (LPI) and Systemic Lupus Erythematosus (SLE).

"At the very beginning, we saw which clinical services were in urgent need. Innovation has propelled GoBroad Healthcare Group to new heights, attracting top talent around the world," said the Mr. Zhang, CEO of GoBroad. "As we develop our own competencies in research and clinical treatment in hematologic malignancies, we'd like to work with industry-leading experts and professionals across the globe to further develop our capabilities."

Powered by the expertise of Mayo Clinic and led by the Chief Physician at the Pathobiology Department of Peking University Health Science Center, GoBroad Healthcare Group has built a laboratory for integrated diagnostics to facilitate data-driven clinical decision-making and enhancement of patient services.

GoBroad values talent. At GoBroad Healthcare Group, experts can work on their research and clinical treatments freely, without administrative requirements. They also can work alongside a digitalized operations system; the healthcare group even rolled out digital products created for the specific clinical needs of healthcare professionals. In addition to attracting talent, GoBroad has also been committed to talent nurturing. Since the first day, the healthcare group has been partnering with top academic institutions such as Tongji University, Beijing University of Chinese Medicine and the Institute of Hematology & Blood Diseases Hospital at Tianjin in a range of educational programs.

About China Cancer Immunotherapy and Targeting Therapy Conference & GoBroad Annual Medical Conference

First launched in 2019, the event was joined by over 500 prominent medical experts across the globe to present the latest development, innovative insights in the field. Prof. Xiaodong Wang, member of the National Academy of Sciences, USA and director of China's National Institute Of Biological Sciences (NIBS), Prof. Mitchell S. Cairo of New York Medical College, Prof. J. Joseph Melenhorst of University of Pennsylvania and faculties from Mayo Clinic, Massachusetts General Hospital, Memorial Sloan-Kettering Cancer Center and City of Hope National Medical Centre are invited to give keynote speeches.

About GoBroad Healthcare Group

Invested by Hillhouse Capital, GoBroad Healthcare Group is dedicated to creating a medical service and technological innovation platform integrating pharmaceutical production and research, with a focus on blood diseases and tumours, among other medical fields. Its medical ecosystem covers the entire hospital supply chain. From clinical laboratories, a medical imaging facility, and big data centres to biotherapy research and treatment. Currently, the group has three homoeopathy R&D centres and five hospitals in Beijing, Shanghai and Guangdong, with a total of 800 beds and 88 hematopoietic stem cell transplant wards.

SOURCE GoBroad Healthcare Group

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FDA Clears Jointechlabs’ MiniTC for Point-of-Care Fat Tissue Processing and its Broad Range of Applications – PRNewswire

Posted: August 26, 2020 at 7:59 pm

SAN FRANCISCO, Aug. 26, 2020 /PRNewswire/ --Jointechlabs a leader in point-of-care regenerative medicine therapies today announced that the U.S. Food and Drug Administration (FDA) cleared the company's MiniTCfor point-of-care fat tissue processing designed to obtain microfat (or fat grafts), for multiple indications. Jointechlabs plans to focus on a range of therapeutic areas including medical aesthetics, plastic surgery, orthobiologics and wound healing.

"The FDA clearance of MiniTC represents an important step forward in the regenerative medicine market," said Nathan Katz, Jointechlabs' CEO. "The company's comprehensive and proprietary technology provides a variety of tissue reconstruction and regeneration options, enabling healthcare practitioners in medical centers, hospitals and clinics to provide safe, reliable and cost-effective cell enriched fat grafts at the point-of-care."

MiniTC is a disposable, closed loop medical device that can be used in the clinic setting, with no change in infrastructure, eliminating the need for manual processing of fat tissue in the lab. Also, the device is less costly,cumbersome and labor intensive compared to what currently exists. MiniTC's performance has been validated in vitro and in vivo, including an observational orthopedic study in Israel and the UAE, involving 47 patients with 92% reporting functional improvement and no complications. Additionally, it was validated in clinical studies with lymphoedema patients as well as in the areas of facial aesthetics, hair regrowth and wound care.

"Jointechlabs' MiniTC device is easy to use and effective," said Joseph Purita, M.D., orthopedic surgeon and director of the Institute of Regenerative Medicine in Boca Raton, Florida."It is encouraging to see the continuing development of new technology for regenerative medicine that is compliant with FDA guidelines."

Microfat IsolationMiniTC allows for processing of adipose (fat) tissue without exposure to the external environment. The final product of the processing is a fine washed fractured fat tissue known as fat graft or microfat. When implanted by injection, the essential effect can be attributed to the preservation of the integrity of fat tissue and the stromal cells within its natural niche. Together it constitutes structural factors that trigger the reconstruction, regeneration and healing of connective tissues.It's a gentle process that uses an individual's own fat tissue tocushion and support areas of injury or damage as the body heals itself.

Pipeline ProductsJointechlabs has an extensive development program. In addition to MiniTC, the company's Mini-Stem a patented, disposable, closed loop medical device is pending approval in Europe (and under investigation in other countries) for isolation of stem cell fraction (SVF) from fat. Mini-Stem will enable doctors to provide safe, reliable, cost-effective non-surgical stem cell treatments at the point-of-care. Mini-Stem will serve as a platform for cell therapies and is well poised to target the developing regenerative medicine market, unlike any of the current devices.Additionally, Jointechlabs is developing proprietary stem cell-scaffold product as a biologic therapy for osteoarthritis, for approval under the FDA's fast-track program. A portion of the pre-clinical study for JTL-T-01 is funded by NIH's small business grant (SBIR grant) in collaboration with Rush University.

Headquartered in San Francisco, Jointechlabs is recognized as an experienced and respected emerging world leader in point-of-care regenerative medicine therapies. With its devices and technology, Jointechlabs enables healthcare practitioners to provide safe, reliable, cost-effective non-surgical regenerative medicine treatments at the point-of-care.For more information, please visit: http://jointechlabs.com/.

Media Contact:Betsy Levy | Phone: (415) 377-3112 | Email: [emailprotected]

SOURCE Jointechlabs

Redefining Adipose Technology

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