Stem Cell Clinic

Metabolic dysregulation: origins of neurodegenerative disease – Health Europa

By Stem Cell Medicine

A new study, published in the journal Neuron, implicates metabolic dysregulation in neurodegenerative diseases leading to altered calcium homeostasis in neurons as the underlying cause of cerebellar ataxias.

This study not only tells us about how SCA7 begins at a basic mechanistic level, but it also provides a variety of therapeutic opportunities to treat SCA7 and other ataxias, said Al La Spada, MD, PhD, professor of Neurology, Neurobiology, and Cell Biology, at the Duke School of Medicine, and the studys senior author.

SCA7 is an inherited neurodegenerative disorder that causes progressive problems with vision, movement, and balance. Individuals with SCA7 have CAG-polyglutamine repeat expansions in one of their genes; these expansions lead to progressive neuronal death in the cerebellum. SCA7 has no cure or disease-modifying therapies.

La Spada and colleagues performed transcriptome analysis on mice living with SCA7. These mice displayed down-regulation of genes that controlled calcium flux and abnormal calcium-dependent membrane excitability in neurons in their cerebellum.

La Spadas team also linked dysfunction of the protein Sirtuin 1 (Sirt1) in the development of cerebellar ataxia. Sirt1 is a master regulator protein associated both with improved neuronal health and with reduced overall neurodegenerative effects associated with aging.La Spadas team observed reduced activity of Sirt1 in SCA7 mice; this reduced activity was associated with depletion of NAD+, a molecule important for metabolic functions and for catalysing the activity of numerous enzymes, including Sirt1.

When the team crossed mouse models of SCA7 with Sirt1 transgenic mice, they found improvements in cerebellar degeneration, calcium flux defects, and membrane excitability. They also found that NAD+ repletion rescued SCA7 disease phenotypes in both mouse models and human stem cell-derived neurons from patients.

These findings elucidate Sirt1s role in neuroprotection by promoting calcium regulation and describe changes in NAD+ metabolism that reduce the activity of Sirt1 in neurodegenerative disease.

Colleen Stoyas, PhD, first author of the study, and a postdoctoral fellow at the Genomics Institute of the Novartis Research Foundation in San Diego, said: Sirt1 has been known to be neuroprotective, but its a little unclear as to why.

Tying NAD+ metabolism and Sirt1 activity to a crucial neuronal functional pathway offers a handful of ways to intervene that could be potentially useful and practical to patients.

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Metabolic dysregulation: origins of neurodegenerative disease - Health Europa

Inside the US-Iran prisoner swap, and what comes next – Al-Monitor

By Stem Cell Medicine

Days before an Iranian stem cell scientist was due to plead guilty and be sentenced to time served by an Atlanta judge as part of a carefully negotiated prisoner swap that would lead to the release by Iran of Princeton graduate student Xiyue Wang, a potential spoiler emerged.

State Department Iran envoy Brian Hook sent a message to the Swiss and Iranians that former New Mexico governor and US Ambassador to the United Nations Bill Richardson was not authorized to negotiate the swap by the US government, according to a person involved in the negotiations. Instead, the Justice Department directed the USattorney in Atlanta to drop all charges against the stem cell scientist, Masoud Soleimani.

We had a plea agreement that had been agreed to by the US attorney in Atlanta and defense counsel, and was awaiting the judges acceptance on Dec. 11, former Kansas Democratic Rep. James Slattery, who worked pro bono to try to help attorney JasonPoblete secure Wangs release, told Al-Monitor. The court date was set for Dec. 11 for the judge to review the plea agreement. It was certain to be approved by a federal judge. After that, Dr. Soleimani would have been sentenced to time served and released.

And then the Justice Department intervenes with the US attorney, and basically directs the US attorney to drop all charges, Slattery continued. Thats how that all happened.

The swap proceeded in Zurich on Dec. 8, with the charges dropped against Soleimani rather than a plea deal. Hook had flown on a plane with Soleimani, who was in the custody of US marshals until he was turned over to Iranian officials. Wang was flown to Zurich from Tehran on a flight with Iranian Foreign Minister Mohammad Javad Zarif and a senior foreign ministry adviser on Latin American affairs, Mohsen Baharvand.

Hook subsequently said that he and Baharvand did not converse at the swap, calling it a missed opportunity, and suggesting that Baharvand may not have been authorized to speak with a USofficial.

We demonstrated with the prisoner exchange that we know how to work together and reach a deal, Hook toldan audience at the Council on Foreign Relationson Dec. 12.I do hope this exchange is a first step.

Hook did not immediately respond to a query from Al-Monitor on why he had allegedly intervened in the potential swap preparations in the final days, before subsequently jumping in and claiming credit.

Mickey Bergman, the vice president of the Richardson Centerfor Global Engagement which had been approached by the Wang family as well as others held in Iran, Syria, Venezuela, North Korea and Russia to try to secure their release, and had been engaged with both Zarif and officials at the National Security Council and Justice Department for months said the important thing is that Wang was home.

"The Wang-Soleimani exchange proved to the Iranians that we can deliver, not only talk; and it proved to us, including the US government, that the Iranians are good on their promise to Richardson, Bergman told Al-Monitor. This is very important as there are more Americans in Iran that we want to bring home."

"We work on behalf of the families, Bergman said. While governments have a complex set of interests with any foreign government, we have a singular one: Bring the person home. While we understand the 'bigger picture,' that means that we often need to 'cook' an arrangement on our own, and introduce it to the government only when we feel it is set, otherwise we allow spoilers who don't want a deal, to spoil."

I wish they understood this is not a one-time game, Bergman said of government officials jumping in at the last minute to try to seize control of or credit for a sensitive exchange, noting there are other prisoners whose release they are working to secure.

Bergman said he and Richardson were encouraged by a meetingthey held with Zarif on the sidelines of the Doha Forum on Dec. 15 onthe prospect of securing the homecoming of others held by Iran, including Navy veteran Michael White. They are also working on the case of former FBI agent Bob Levinson, who went missing on Irans Kish Island in 2007.

"Following the Wang-Soleimani exchange, Gov.Richardson sat with Foreign Minster Zarif in Doha, closing the loop on the latest exchange and discussing further humanitarian exchanges, Bergman said."We are working on behalf of and at the request of Michael White's family as well as Bob Levinson's family. Naturally, those two cases were discussed in our meeting with FM Zarif. The discussion was productive. There is a lot of heavy lifting to do, but we are hopeful."

Though Hook, Ivanka Trump and Treasury Secretary Steven Mnuchin also attended the Doha Forum, Zarif said there had been no Iranian official encounters with members of the US government delegation there. No meeting or even accidental encounter in Doha, he told Al-Monitor.

If the Trump administration wants to get to talks with Iran, it should adjust its approach, Bergman said.

If the US wanted to facilitate meaningful dialogue with Iran, either in Zurich during the exchange or in Doha after the exchange, he suggested holding off on announcing new sanctions. Instead, make a positive statement, like the president actually did, but back it up in actions, don't follow it up with slapping additional sanctions. That proved to the Iranians that they couldnt trust the president."

Slattery, who was acquainted with Iransambassador to the United Nations, Majid Takht-Ravanchi, who did his university and graduate studies in Kansas, said he hoped the United Statesand Iran could build on the success of Wangs release.

I learned a lot during these negotiations working with Jason Poblete and Gov. Bill Richardson and the Iranian officials, the former Kansas congressmantold Al-Monitor by email. The Iranian officials did exactly what they promised me they would do.

But Slattery said he had concerns about prisoner swaps, and respected the Justice Departments concerns about politicizing, or the appearance of politicizing, the US legal system. He also urged the US government to ease sanctions thatrestrictIrans ability to procure medicines, because banks donot have the assurances they need to facilitate the transaction.

I do not like prisoner swaps because they can politicize our legal system, he said. We must never charge someone with a crime for political reasons nor should we release someone from prison who has been charged with violating US law for political reasons.Criminal cases should be processed based on the law and facts.

I hope the [US] administration will actively pursue the sale of medicines to Iranthat are excluded from US sanctions, Slattery said. "The people of Iran, including children, senior citizens and the critically ill are suffering from the lack of medicines. USsanctions permit the sale of medicines. Preventing the sale of medicines by denying banks the assurances they need to facilitate the medicine sale transactions empowers the Revolutionary Guard in Iran while causinggreat suffering among the people. This does not serve US interests or Israeli interests.

I urge the administration to be as bold with its diplomatic outreach to Iran as it has been to North Korea, Slattery concluded.The rewards will be far greater.

I believe it's in the interest of all to engage in a comprehensive exchange of detainees on both sides, an Iranian diplomat, speaking not for attribution, said Wednesday.

Nizar Zakka, a Lebanese US green card holder released by Iran in June, said that he and Wangs wife,Hua Qu,had met with US national security adviser Robert OBrien in September and sought to persuade him that the United Statesshould respond to Zarifs overtures that he had authority to negotiate a prisoner swap.

We were very clear, why do you not respond to Zarif, Zakka told Al-Monitor. He said they tried to impress on OBrien, who previously served as Trumps special hostage envoy, that it was the first time that Zarif was mentioning names of Iranians held by the United States that could be potentially released in a swap,

Zakka, who said he was in the same cell with Wang in Iran for two years, expressed joy that he was back. We stayed next to each other for two years, Zakka said. He is a great guy. I am so glad that he is back.

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Inside the US-Iran prisoner swap, and what comes next - Al-Monitor

BELINDA Trial Tests Earlier Use of Tisa-Cel in Aggressive B-Cell Non-Hodgkin Lymphoma – Cancer Therapy Advisor

By Stem Cell Treatment

A multicenter phase 3 trial began enrolling patients earlier this year to test the safety and efficacy of tisagenlecleucel (tisa-cel/Kymriah) as a second-line therapy for aggressive B-cell non-Hodgkin lymphoma (NHL).

Tisa-cel, an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, has already been approved for use in patients who have relapsed after receiving 2 lines of therapy. But its possible that, if administered sooner across treatment regimens, CAR-T could help more patients avoid relapse. The new study on this topic, known as BELINDA, aims to answer that question.

The hypothesis is that CAR-T cells should improve upon progression-free survival as compared to standard of care, said Michael Bishop, MD, director of the hematopoietic stem cell transplantation program at the University of Chicago Medicine, Illinois, and one of the BELINDA coauthors. Dr Bishop presented the study protocol at the 34th Annual Meeting & Preconference Programs of the Society for Immunotherapy of Cancer, or SITC 2019, in National Harbor, Maryland.1

Around a third of patients with non-Hodgkin lymphoma (NHL) will relapse after receiving first-line immunochemotherapy, and another 10% to 15% do not respond to initial treatment. For these patients, the outlook is grim: median overall survival is less than 12 months. Second-line treatment consists of high-dose chemotherapy combined with autologous stem cell transplant, but fewer than half of patients will qualify for a transplant. Youve got half the patients who wont get the transplant, and the other half that do, only a quarter of those will have sustained remission, said Dr Bishop. Its a large unmet patient need.

Dr Bishop went on to explain that previous trials have indicated that some 30% to 40% of patients receiving CAR-T therapy for multiply relapsed or refractory NHL have achieved long-term remission. The other exciting thing about this trial is its moving CAR-T up the treatment algorithm, he said.

The BELINDA trial is a multicenter, phase 3, open-label trial, in which patients are randomly selected to receive treatment in 1 of 2 arms: tisa-cel, or standard of care. Similar to the ZUMA-7 trial,2 which tested another CAR-T therapy called axicabtagene ciloleucel (Yescarta), BELINDA is enrolling patients whose disease either does not respond to first-line therapy (rituximab and anthracycline) or has returned within 12 months, and who are eligible for autologous stem cell transplant.

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BELINDA Trial Tests Earlier Use of Tisa-Cel in Aggressive B-Cell Non-Hodgkin Lymphoma - Cancer Therapy Advisor

‘With six weeks in isolation for leukaemia treatment, what you really need is someone to give you a good laugh’ – Telegraph.co.uk

By Stem Cell Treatment

Patients are very isolated. The staff nurses on the ward will obviously go and see the patient, but youve got long periods of time on your own. It is easy to imagine that, with the chaos of the Christmas period, the loneliness for inpatients will grow even more intense.

And that loneliness is frightening for patients, says Smith: When youre there, in isolation for six weeks, your mind whirrs. Your relatives can come, but only if they have no coughsor colds or diseases. They dont want to come if theyre going to makeyou poorly. But Shirley comes in once a week and talks to me, he says, with a chuckle.

Emmerson explains: I work with the nurses, and they tell me whos where, and who they think would like a visit, or if theres anything I can do. And then, I just go along and introduce myself. Thats how I met Steve. Yes, it was during my first blast of chemo, in May, Smith begins, and Emmerson adds, smiling: Ive been there all the way through.

This consistent support has been invaluable to Smith, who recalls sitting alone in his room, wondering whether the chemotherapy was working, and what would happen next. It does play with your head, he acknowledges, as you sit by yourself, thinking: whats going on? A typical Thursday when Smith is an inpatient goes like this: he wakes and has breakfast between 8-9am (I try to get a full English out of it, he jokes, though he soberly acknowledges that the treatment makes most patients lose their appetite.)

Then he might watch some television and await Emmersons visit at about 10.30am. From day one, Shirley would always laugh with me, he explains. Shirley would say, Have you thought about this or Have you tried that but what I really got out of it was having someone to sit and talk to about my family, about her family. Its just a giggle, but that laughter makes you feel better. Emmerson would stay until around lunchtime.

In the afternoons, Emmerson heads to the bright haematology outpatient ward, which sees 500 patients each week. Here, the waiting room has a side room with a collection of row after row of pamphlets from Macmillan and other charities.

In a voice inaudible to the dozen or so waiting patients, with their accompanying family members, Chatten explains that the room used to be closed off, but a bereaved family donated money so it could be spruced up and opened to the waiting room, so the range of available help would be easily discoverable.

Continued here:
'With six weeks in isolation for leukaemia treatment, what you really need is someone to give you a good laugh' - Telegraph.co.uk

Merck’s KEYTRUDA (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or…

By Stem Cell Treatment

Advanced renal cell carcinoma and head and neck cancer have historically been associated with poor outcomes and new treatment options are needed in Japan, said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. Todays approval of three new first-line KEYTRUDA regimens represents a significant milestone for patients diagnosed with these aggressive forms of cancer and will provide patients in Japan with important alternatives to standard therapies.

The approval for KEYTRUDA in combination with axitinib for radically unresectable or metastatic RCC is based on results from the KEYNOTE-426 trial, in which KEYTRUDA in combination with axitinib demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) (HR=0.53 [95% CI, 0.38-0.74]; p=0.00005) and progression-free survival (PFS) (HR=0.69 [95% CI, 0.56-0.84]; p=0.00012) compared to sunitinib monotherapy.

The approval for KEYTRUDA for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer is based on results from the Phase 3 KEYNOTE-048 trial which evaluated KEYTRUDA in combination with platinum and 5-fluorouracil (5-FU), or KEYTRUDA monotherapy compared with standard treatment (cetuximab in combination with platinum and 5-FU), as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma. In the trial, KEYTRUDA in combination with platinum and 5-FU significantly prolonged OS (HR=0.77 [95% CI, 0.63-0.93]; p=0.00335) compared with standard treatment. As monotherapy, KEYTRUDA demonstrated non-inferiority (HR=0.85 [95% CI, 0.71-1.03]; p=0.00014) compared with standard treatment. Additionally, KEYTRUDA monotherapy demonstrated a statistically significant improvement in OS in patients whose tumors expressed PD-L1 (CPS 1) compared with standard treatment.

Last year, an estimated 850,000 new cancer diagnoses were made in Japan alone, underscoring the critical need for innovative research and development to identify additional treatment options, said Jannie Oosthuizen, managing director of MSD in Japan. The new approvals of KEYTRUDA in advanced renal cell carcinoma and head and neck cancer build on previous approvals in melanoma, advanced non-small cell lung cancer and advanced MSI-H cancers, allowing us to bring KEYTRUDA to even more patients in Japan.

Renal cell carcinoma is by far the most common type of kidney cancer, with approximately 403,000 cases of kidney cancer diagnosed worldwide in 2018 and about 175,000 deaths from the disease. In Japan, it is estimated there were more than 24,000 people diagnosed with kidney cancer, and more than 8,000 deaths occurred in 2018.

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. It is estimated that there were more than 705,000 new cases of head and neck cancer diagnosed and over 358,000 deaths from the disease worldwide in 2018. In Japan, it is estimated that more than 22,000 new cases of head and neck cancer were diagnosed, and more than 8,000 deaths occurred in 2018.

About KEYTRUDA (pembrolizumab) Injection

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected Indications for KEYTRUDA (pembrolizumab) in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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Merck's KEYTRUDA (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or...

Rett Syndrome Therapies are Focus of Stemonix-Atomwise Partnership – Rett Syndrome News

By Stem Cell Treatment

StemoniX and Atomwise will work together to discover and develop small molecules that could be potential new therapies for people with Rett syndrome.

This collaboration will take advantage of StemoniXs human microOrgan platform and combines it with Atomwises artificial intelligence technology to expedite the development process and increase the chances of clinical success of new therapeutic molecules.

The joint venture brings together the complementary technologies of StemoniX and Atomwise, creating an opportunity to go from model to molecule to validated drug in a fraction of the time and cost required with traditional methods, Ping Yeh, co-founder and CEO of StemoniX, said in a press release.

Atomwise is a great partner for a notoriously challenging disease area. Their expertise will enable drug discovery on historically undruggable targets and provide new opportunities for treating rare neurological diseases, he added.

Researchers at StemoniX use human induced pluripotent stem cells (iPSCs) to build ready-to-use functional tissues that mimic the biological responses of human organs. iPSCs are developed by reprogramming cells to revert to an embryonic-like state which are then able to differentiate into all cell types.

With the companys microOrgan platform, researchers have used iPSCs collected from patients with Rett syndrome to build 3D microbrains made of nerve cells and astrocytes (cells that support neurons, respond to injury, and regulate blood flow and inflammation in the brain). Such microbrains recapitulate features of the disease.

This platform could provide greater accuracy and consistency to clinical trials, according to the company.

In turn, Atomwises artificial intelligence technology uses statistical approaches that were designed to overcome limitations of current preclinical treatment discovery and development methods.

It combines information from millions of measurements and thousands of protein structures to predict the binding of small molecules to protein targets. This approach makes it possible to pursue a comprehensive therapy discovery with unparalleled precision and accuracy, according to Atomwise.

New technologies and approaches are vital to address the needs of patients, saidAbraham Heifets, PhD, co-founder and CEO of Atomwise. StemoniX has made remarkable progress with their microBrain 3D platform and its application to Rett syndrome. It is a potentially powerful tool to rapidly evaluate compound efficacy and assess their suitability for clinical trials, and we are excited to partner with them.

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Rett Syndrome Therapies are Focus of Stemonix-Atomwise Partnership - Rett Syndrome News

BrainStorm Cell Therapeutics Wins 2020 ‘Buzz of BIO’ Award – Multiple Sclerosis News Today

By Stem Cell Clinic

For its promising investigational therapeutic approach to neurodegenerative diseases, including progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics is theBuzz of BIO 2020 winnerin the Public Therapeutic Biotech category.

The Buzz of BIO contest identifies U.S. companies with groundbreaking, early-stage potential to improve lives. The event also is anopportunity to make investor connections that could take products to the next phase.

Ten biotechnology companies are nominated in each of the three categories of Buzz of BIO: Public Therapeutic Biotech, Private Therapeutic Biotech, and Diagnostics and Beyond. In the Public Therapeutic Biotech category that BrainStorm won, nominated companies must be actively developing a publicly traded human treatment intended for review by theU.S. Food and Drug Administration.

As a developer of autologous cellular therapies for debilitating neurodegenerative diseases, BrainStorm is testing its investigational therapy,NurOwn, in progressive MS patients, for whom treatment options are limited.

The therapy is based on patients own bone marrow-derived mesenchymal stem cells that are engineered to secrete growth factors. Such factors are thought to protect nerves from damage, promote the repair of myelin (the protective coat of neurons that is destroyed in MS), and ultimately slow or stabilize disease progression.

BrainStorms current open-label Phase 2 clinical study (NCT03799718) is enrolling up to 20 adults with either secondary progressive or primary progressive MS at three U.S. sites:theKeck School of Medicine of USC, the Stanford School of Medicine, and theCleveland Clinic. After undergoing a bone marrow aspiration to collect cells, each participant will receive three intrathecal (injected into the spinal cord) NurOwn cell transplants within 16 weeks, and will be tracked for at least another 12 weeks to assess safety and effectiveness. Contact information for the trial centers is available here.

Thanks to everyone who voted for BrainStorm during the Buzz of BIO competition,Chaim Lebovits, BrainStorm president and CEO, said in a press release.

As the winner of the contest, BrainStorm also was invited to givea presentation at theBio CEO & Investor Conference, to be held Feb. 1011 in New York City.

The entire management team at BrainStorm was very pleased with the results of this competition, and we look forward to presenting to an audience of accredited investors who may benefit from the companys story, said Lebovits. We thank the BIO[Biotechnology Innovation Organization] team for singling out BrainStorms NurOwn as a key technology with the potential to improve lives.

NurOwn cells also are being tested in a Phase 3 trial (NCT03280056) in patients with amyotrophic lateral sclerosis (ALS).

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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BrainStorm Cell Therapeutics Wins 2020 'Buzz of BIO' Award - Multiple Sclerosis News Today

Chinese Researchers Created the First PigMonkey Chimera – Science Times

By Embryonic Stem Cells

(Photo : Pixabay)

Chinese researchers developed two piglets that were a hybrid of a pig and a monkey.

Monkey stem cells were injected into fertilized pig embryos to generate the pigmonkey chimera. These were subsequently implanted intosurrogate sows.Chimeras were a result of these piglets, which means that they contained DNA from a pig and a monkey.

"This is the first report of full-term pig-monkey chimeras," co-author Tang Hai, a researcher at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing, told New Scientist.

The main goal of Hai and his co-researchers were for the growth of human organs in animals for transplant procedures. The team has received ethical qualms related to the development ofhumananimal chimeras.

Mechanism on the Growth of the PigMonkey Chimera

The cells of cynomolgus monkeys (Macaca fascicularis) were grown in lab dishes. TheDNA cellswere provided steps to build a fluorescent protein that aimed to change the DNA. A bright green glow was a result of this protein. Embryonic stem cells resulted from these luminescent cells that were injected into prepared pig embryos. Monkey cells were tracked by the researchers through these luminescent spots.

A total of 4,000 embryos were recipients of the monkey cell injection and were subsequently implanted in surrogate pigs. Ten piglets were born out of these sows but only two grew both pig and monkey cells. The team used the luminescent protein to scan for the monkey cells through different organs. The hybrid chimeras were comprised of 99% pig as there is one in 1,000 monkey cells in each organ.

The low ratio of monkey to pig cells still is greater compared with the 2017 humanpig chimera that was grown by scientists. The said chimera was only permitted to develop for a month since there is a possibility that the brain might grow human cells and provide the animal with a human-like consciousness.

Ethical Issues

The pressure from the scientific ethics committee did not stop the team from creating humanmonkey chimeras early this 2019. The results of the said experiment were not published, but the researchers only allowed the humanprimate chimera a few weeks to develop.

Despite the success achieved by Hai and his co-authors, stem cell biologist Paul Knoepler of the University of California, Davis was not impressed with the results as it is discouraging because of the low ration of monkey-to-pig cells.

"The exact reason for the piglets' death remains "unclear," Hai told New Scientist, but he said that he suspects the deaths are linked to the in vitro fertilization (IVF) procedure rather than the injection of monkeyDNA. Other scientists have also found that IVF doesn't consistently work in pigs, according to a 2019 report in the journalTheriogenology," as reported byLive Science.

Hai and his team aim to increase the ratio of monkey cells to pig cells in future chimeras. The researchers aim to be able to grow human organs in animals for organ transplant procedures and to help in the field of human health.

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Chinese Researchers Created the First PigMonkey Chimera - Science Times

A Modern Treatment for the Age-Old Problem that is Hair Loss – Communal News

By Platelet Rich Plasma Injections

Hair loss is one of those things that can be incredibly detrimental to numerous parts of a persons life. This problem is not one that only affects people aesthetically; its often something that can be really detrimental to a persons confidence to the point it can lead to social isolation and difficulties in the workplace. While some people are quite happy to get out the clippers and call it a day, for a lot of people their hair is extremely important to them and a huge part of how they express and represent themselves to others, and when this is taken away from them it can be a significant shock.

Hair Transplants Work But Arent Always Ideal

If you are contemplating hair transplant procedures, you are likely somewhat aware of the process already, but there are a few things that people that receive hair transplants often have to say about them which you may not be aware of yet. While they do work, in some circumstances very well, they are time-intensive, uncomfortable and can lead to scarring. Depending on the amount of hair you are having transplanted you may be in the chair for a very long time, and depending on the amount of hair that survives the transplant you may end up requiring even more time.

Many people also find the popping sensation of this treatment quite uncomfortable, and when the treatment is quite time-intensive, this can become something far less than pleasant. There is also the issue of scarring, and if you are concerned, you may end up losing more hair over time or end up with significant balding this may leave you with not just a bald head, but now a scarred one as well. Modern approaches to hair transplants using direct follicle transplant are far better in this regard than the older method of using strips, but this is still something to be aware of when thinking about this treatment option for hair loss.

Hair Loss is Complicated

Hair loss is extremely complex, and its frequently understated how much so when the reality is there are so many potential causes for hair loss and types of hair loss the same treatments arent ideal for everyone. Often a secondary condition may be causing the hair loss that needs to be addressed. Its essential that you seek the assistance of someone experienced in treating hair loss rather than trying to mask it yourself with off the shelf products, wigs, or less than ideal products like spray-on hair.

An Interesting Treatment for a Difficult Condition

However, one treatment that is growing in popularity and is suitable for a lot of people is PRP hair loss treatment using platelet-rich plasma injections. What makes this treatment quite interesting is that it takes advantage of mechanisms present in your own body and amplifies them by concentrating specific elements of your blood. While this can sound quite dramatic, for patients receiving PRP hair loss treatment, its actually not; it merely requires a small blood sample that is then processed and prepared for reinjection. PRP injections when used to treat hair loss are then applied with a series of precision injections into the scalp. Over 30 growth factors have been identified in platelets, so when the platelets are concentrated from a blood sample and activated by calcium chloride, they have an often impressive effect on hair regeneration when applied to the scalp.

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A Modern Treatment for the Age-Old Problem that is Hair Loss - Communal News

Exclusive Research On Joint Pain Injections Market SWOT Analysis including Key Players – Sound On Sound Fest

By Platelet Rich Plasma Injections

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