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Saturday, May 4, 2019

AUA’19: PET/CT with 18F-fluciclovine in post-treatment prostate ca recurrence

Detection and treatment of micrometastatic prostate cancer before radiographic evidence have been widely studied. However, the currently used computed tomography (CT), bone scans and even multiparametric MRI lack sensitivity.  Positron emission tomography/computed tomography (PET/CT) with nuclear radiotracers such as NaF, F-FDG and choline/acetate show some promise, but still miss a large proportion of recurrent disease. PET/CT with 18F-fluciclovine has been shown to improve the detection of recurrent prostate cancer and detect up to 57% of recurrences in previously treated prostate cancer, not detected by CT or bone scan.
In the presented retrospective study, the authors evaluated the ability of 18F-fluciclovine to change treatment, and also tried to identify an optimal PSA cut-off to screen for recurrent prostate cancer. Patients who received 18F-fluciclovine for recurrent PCa following treatment were analyzed, and patients with positive scans were compared to those who had negative scans. Also, a receiver-operator characteristic (ROC) curve was used to estimate the optimal PSA cut-off to predict for a positive scan.
According to the authors’ presentation, 84 patients with post-treatment suspected recurrent prostate cancer received 18F-fluciclovine PET/CT at a single institution. In the final analysis, 78 patients were included, divided into those with (n=53) and those without 18F-fluciclovine PET/CT positivity (n=25). 18F-fluciclovine was demonstrated to predict radiographic recurrence or metastatic disease in 53 patients (67.9%). The following parameters were similar between both groups: Age, number of comorbidities, mean PSA at diagnosis, Gleason score, Gleason grade group, clinical stage, treatment type received, nadir PSA, PSA velocity, and time from diagnosis to scan. The following covariates were shown to be associated with a positive scan: a higher mean PSA at the time of the scan (6.29 vs. 1.1 ng/ml, p = 0.01), receiving salvage radiotherapy to the prostatic bed (55% vs. 27%, p<0.01), any use of androgen deprivation therapy (ADT) (62% vs. 32%, p=0.016), and a higher mean number of scans since PSA began to rise (2.77 vs. 1,59, p = 0.042), as seen in table 1.
AUA2019 UroToday PETCT with 18F fluciclovine 1a
Recurrence sites included: lymph nodes in 65.8%, bone in 22.5%, prostatic bed in 9.2%, and others, such as lung and mediastinum, in 2.5%. A PSA of 0.5 ng/ml was identified from a ROC curve for detecting recurrent/metastatic disease, with a sensitivity of 81.13%, and a specificity of 71.43% (figure 1).
AUA2019 UroToday PETCT with 18F fluciclovine 2a
Alteration of the treatment plan occurred in 34/58 (58.6%) patients.The most common treatment alterations included directed stereotactic body radiation therapy (SBRT) (16/34, 47%), salvage surgical resection (4/34, 11.7%), and continuous ADT (3/34, 8.7%).
The authors concluded that 18F-fluciclovine PET/CT detected recurrence in almost 68% of patients with rising PSA. The most common site of recurrence was within the pelvic lymph nodes. Alteration of treatment plans occurred in 58% of the time with salvage SBRT being the most common treatment modality. Any use of salvage therapy and or ADT were associated with PET/CT positivity. Lastly, a PSA cut-off of 0.5 ng/ml was demonstrated to be a good starting point in identifying patients with recurrent prostate cancer after localized treatment. This was especially true if they have risk factors such as prior salvage therapy or use of ADT.
Presented by: Julio Chong, MD, Icahn School of Medicine at Mount Sinai
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Beyond Meat Just Had the Best IPO of 2019 as Value Soars to $3.8B

Beyond Meat Inc. piled on the market value, serving up the year’s best first day for a U.S. initial public offering.
The maker of vegan beef and sausage substitutes soared, rising as much as 192 percent from its IPO price of $25 share. The shares, which opened at $46, closed their first day of trading Thursday up 163 percent to $65.75 in New York, giving the company a market value of about $3.8 billion.
The first-day pop eclipsed the 81 percent gain by Silk Road Medical Inc. in its U.S. debut last month and was the best for a U.S. listing raising at least $200 million since before the 2008 financial crisis. Globally, Beyond Meat bested the debuts this year of all but a handful of small listings, none of them larger than $22 million.
Beyond Meat raised $241 million from the sale of 9.63 million shares on Wednesday, after increasing its marketing range for them to $23 to $25.
The company’s business and Hollywood celebrity backers, including MicrosoftCorp. co-founder Bill Gates and actor Leonardo DiCaprio, helped explain the investor zeal, along with a growing consumer appetite for meat alternatives.
Investor and actress Jessica Chastain, who is a vegan, said she cooks Beyond Meat products at home, to the approval of her non-vegan husband and friends.

Toronto Burger

“I love any plant-based product,” Chastain said in an interview at the Nasdaq exchange. She said she invested in Beyond Meat after being on set in Toronto and being unable to find a Beyond Burger at an A&W restaurant. “I tried for four months in Canada to get one and it sold out everywhere,” she said.
Chief Executive Officer Ethan Brown doesn’t expect a conflict between making environmentally based decisions and those that serve shareholders.
“Consumers are looking for products that enable them to be healthier and reduce their footprint,” he said in an interview. “Every time we’re making a sale we’re furthering our mission and increasing sales.”

International Potential

One food-industry consultant said investors are taking a lot on faith with money-losing Beyond Meat.
The company’s valuation in its IPO is “entirely reasonable if it’s got internationalizable potential and a great product, and has capacity to make money in its core profit structure,” said Robert Lawson, chief executive officer of London-based Food Strategy Associates. “But it’s not clear that Beyond Meat is that.”
The company will need to expand its product range to succeed outside the U.S., where burgers aren’t as popular, Lawson added.
Consumers are looking for more plant-based meat alternatives because of concerns about health, animal welfare and the environment. Startups like Beyond Meat are tapping into that demand by offering beef-like versions of the veggie burger and other meat products.
Supermarket sales of meat alternatives surged 19.2 percent to $878 million for the year ended Jan. 5, according to data from Nielsen. The field is crowded, with Silicon Valley-based Impossible Foods also placing its meatless burgers in thousands of restaurants, including all Burger King locations. Nestle SA makes a plant-based Incredible Burger, which is available in McDonald’s Corp.’s German locations.

TGI Fridays, Del Taco

Beyond Meat is sold in grocery stores nationwide and is also increasingly being featured on restaurant menus, including TGI Fridays and Carl’s Jr. and now under a new deal with Del Taco Restaurants Inc. Its burger patties, with no cholesterol and 5 grams of saturated fat, are made of pea protein and beet juice, which makes them “bleed” when cooked. That compares with 80 milligrams of cholesterol and 9 grams of saturated fat for a 4-ounce patty of 80 percent lean beef.
And despite the company’s mission, Brown said the company will choose the customer over the planet when necessary.
“Our packaging is not great,” he said, referring to the plastic wrap. “That runs counter to what I believe in in terms of ability to recycle things and the overall footprint of that packaging, but we care about the quality of the product. So we will make trade-offs that make sense for the product and market instead of the most environmental path.”

Shrinking Losses

Beyond Meat shrank its 2018 loss, while its revenue more than doubled for the second year in a row, according to its filings. Last year, it lost $29.9 million on revenue of $87.9 million compared with a 2017 loss of $30.4 million on revenue of $32.6 million.
The company had significant shortages in 2017 and 2018 and has since made significant investments to keep up with demand, Brown said.
“Now it’s about sequencing customers,” he said. Quick-service restaurants have thousands of locations, so supplying them requires a huge jump in output. To keep up, Brown said, the company has been staggering rollouts.
Brown said he wants to eventually lower the price of the company’s products, which currently can cost twice as much as standard ground beef. Beyond Meat wants to sell its products for less than animal protein in the next five years, he said.

McDonald’s Ex-Chief

Beyond Meat’s investors include former McDonald’s Chief Executive Officer Don Thompson and venture capital firm Kleiner Perkins Caufield & Byers LLC, which owns 16 percent of the company, and Twitter Inc. co-founder Ev Williams’s Obvious Ventures with 9 percent, according to its filings.
Its backers had included Tyson Foods Inc., the largest U.S. meat producer. Tyson sold its 6.5 percent stake in Beyond Meat, according to a statement in April. Tyson’s shares were sold both to insiders and new shareholders, Brown said.
The offering was led by Goldman Sachs Group Inc., JPMorgan Chase & Co. and Credit Suisse Group AG. Beyond Meat trades on the Nasdaq Global Market under the symbol BYND.

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Say No To Canadian Drug Imports

Lawmakers in the Sunshine State are looking to our northern neighbor to help them reduce drug prices. The Florida House of Representatives recently passed a bill that would allow the importation and sale of prescription drugs from Canada, where prices are generally lower because the government forcibly controls them.
Florida isn’t the only state to have jumped on this buy-Canadian bandwagon. More than a dozen states are considering or have previously weighed bills to permit the importation of foreign drugs.
Importing drugs from abroad will provide meager savings—if it provides any at all. And it could jeopardize patient safety by dramatically increasing the risk of counterfeit drugs entering the U.S. supply chain.

The case for prescription drug importation seems obvious. Consider Januvia, a drug that treats type 2 diabetes. It sells for more than $1,400 a bottle in the United States—but just $340 in Canada. Why should Americans pay more than their brethren across the border for the same drugs?
Canada’s price controls on drugs ensure that its citizens do not pay their fair share of the cost of innovation. By paying higher prices, Americans effectively subsidize the development of new drugs for the rest of the world. And that’s expensive. It takes about $2.6 billion to develop and bring a new drug to market. Just under 12% of drugs that enter clinical development actually garner regulatory approval.
But in the aggregate, prescription drug importation won’t save U.S. consumers much money. According to one study of the issue by the Congressional Budget Office, importing drugs from Canada “would produce a negligible reduction in drug spending.”
The vast majority of drugs Americans take are generics, which cost about the same in the United States as they do in Canada. So the only potential savings from importation will be on a small number of brand-name drugs.
It’s one thing for an individual to cross the border to buy a three-month supply of drugs at the margin. It’s another for a state government to import drugs en masse for thousands of people. If drug companies discovered that the drugs they’d made for sale in Canada were all being rerouted to Florida, they might stop selling drugs in Canada altogether. Or they might make sales contingent on the drugs not being exported to the United States.
Remember, too, that Canada is a relatively small country. Its entire population—37.5 million—is lower than California’s estimated 2018 population of 39.6 million. The combined population of Florida and the 15 other states that have been considering Canadian drug imports is more than double Canada’s.
“Canadian shelves would run dry,” Steve Morgan, a Canadian health economist, told Politico recently. Canada’s drug supply would be exhausted in 224 days—less than eight months—if just 10% of U.S. prescriptions were filled with Canadian drugs, according to a study published in the Canadian Pharmacists Journal.
Canadian officials aren’t likely to stand by idly as life-saving medicines intended for their citizens head south into Americans’ medicine cabinets.
So the purported benefits of importation are unlikely to materialize. The dangers, however, are very real.
In a letter to the Wall Street Journal, Mary Mayhew, the new Secretary of the Florida Agency for Health Care Administration, called drug importation “no more risky than a trip to your local Walgreens.”
The evidence suggests otherwise. Federal investigations have repeatedly found drugs labeled as being from Canada originated in other nations. A 2005 operation conducted by the Food and Drug Administration found that nearly half of the imported drugs intercepted from four select countries were purported to be from “Canadian” internet pharmacies. Of those supposedly “Canadian” drugs, 85% were from 27 other nations. Many were counterfeit.
Health officials in Canada and the United States have issued warnings about the trafficking of adulterated prescription drugs across the two countries’ border. Health Canada told an FDA task force that it “does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.”
The FDA has warned that “medicine bought over the internet from foreign sources . . . may not be safe or effective.” In 2017, four former FDA commissioners—two Democrats, and two Republicans—wrote a letter to Congress expressing their opposition to drug importation. They argued that the FDA wouldn’t be able to sufficiently monitor such sales. That would open the door for manufacturers of counterfeit and substandard drugs to inject their wares into the U.S. drug supply.
Many Americans are struggling to afford medicines they need. But the answer isn’t to sanction imports of dubious origin or quality. It’s to increase competition here by streamlining the drug approval process. The Trump administration has had some success on that front. Last year, the FDA approved a record 59 novel drugs.
The United States doesn’t need to look outside its borders for lower drug prices. Market competition can reduce costs without compromising patient safety.
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China Cosmetic Surgery Site So-Young Soars Again After IPO

China cosmetic surgery information and services site So-Young International soared for a second day today after its U.S. listing, gaining amid broad enthusiasm for shares following an upbeat jobs report and a strong Nasdaq close.
So-Young rose 14% on Friday to close at $20.77. The company earlier this week raised $179.4 million in an IPO, selling 13 million American Depositary Shares at $13.80 each. Nasdaq trading began on Thursday.
So-Young describes itself as “the most popular online destination for discovering, evaluating and reserving medical aesthetic services in China.” So-Young investors include Trustbridge Partners and Orchid Asia. So-Young CEO Jin Xing’s nearly 16% stake was worth more than $300 million at today’s close.
So-Young’s revenue last year increased by 138% from 259.3 million yuan in 2017 to 617.2 million, or $89.8 million. It earned $8 million in profit. The company had 1.4 million monthly average mobile users last year.
Trustbridge is also involved in the upcoming Nasdaq listing of China e-commerce site Yunji. Yunji has raised $121 million in an IPO by offering 11 million shares at $11, the low end of the range of $11 to $13, according to Renaissance Capital.  Existing shareholders Crescent Point and Trustbridge had indicated an interest in purchasing up to $100 million of the deal, accounting for 83% of the transaction, Renaissance said.
China stocks that had been dragged down at the end of last year on worries about U.S.-China trade negotiations have recovered on hopes that the two sides will soon reach an agreement.
Among China bellwether shares traded in the U.S., Alibaba Group rose by 2.5% today to $195.21, its best close since last summer.
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Friday, May 3, 2019

Denosumab in Rheumatoid Arthritis: Protecting the Bone

Combining denosumab (Prolia) with a conventional disease-modifying antirheumatic drug (DMARD) such as methotrexate showed promise for slowing radiographic damage in rheumatoid arthritis (RA), a manufacturer-sponsored phase III trial called DESIRABLEfound.
At 1 year, patients who were randomized to placebo had a change from baseline in their total Sharp score of 1.49 (95% CI 0.99-1.99), while those who received subcutaneous denosumab, 60 mg every 6 months, had a change of 0.99 (95% CI 0.49-1.49, P=0.0235) and those given that dose of denosumab every 3 months had a change of 0.72 (95% CI 0.41-1.03, P=0.0055), according to Tsutomu Takeuchi, MD, PhD, of Keio University School of Medicine in Tokyo, Japan, and colleagues.
In addition, the proportions of patients with no radiographic changes at 12 months were 64.2% in the placebo group, 75.6% in the 6-month group (P=0.0097), and 78.1% in the 3-month group (P=0.0014), the researchers reported online in Annals of the Rheumatic Diseases.
Denosumab is a monoclonal antibody that inhibits the receptor activator of nuclear factor ΚB ligand (RANKL) that is used for the treatment of osteoporosis. Binding of RANKL suppresses bone resorption and may help slow the progression of bone erosions.
“The concept of using osteoporosis drugs in RA to reduce erosions has previously been studied with bisphosphonates, but with very little benefit,” commented John J. “Jack” Cush, MD, of Baylor Research Institute in Dallas, who was not involved in the study.
“The use of denosumab makes a lot more sense given that RA inflammation drives RANK ligand and osteoclast activity to promote local damage and systemic bone loss,” Cush told MedPage Today.
Earlier phase II trials of denosumab demonstrated significant inhibition of bone erosions in patients with RA also given methotrexate, so Takeuchi and colleagues enrolled 654 patients from 2013 to 2015. Mean age was 57, disease duration was slightly over 2 years, and three-quarters were women. Mean total Sharp score at baseline was 14.75.
All patients were taking methotrexate or other conventional DMARDs, but previous treatment with biologics was not permitted. Radiographs of the hands and feet were obtained at baseline, 6 months, and 1 year.
Changes in erosion scores from baseline to 1 year were smaller in the two denosumab groups, but there were no differences in joint space narrowing scores.
The proportion of patients with rapid radiographic progression, defined as annual progression of 5 or more points on the total Sharp score, were 10.6% in the placebo group, 6.9% in the 6-month group (P=0.1785), and 5% in the 3-month group (P=0.0310).
Percent changes in bone mineral density at the lumbar spine were -1.03%, 3.99%, and 4.88%, respectively (P<0.0001 for both denosumab groups). The increases seen in the denosumab groups occurred regardless of whether the patients were taking glucocorticoids.
Patients receiving denosumab also had significant declines in the bone metabolism marker CTX-I, but had no changes on the marker of cartilage turnover COMP.
There were no differences on efficacy outcomes such as the 20%, 50%, and 70% improvement criteria of the American College of Rheumatology (ACR20, 50, and 70) or Disease Activity Scores in 28 joints (DAS28). This lack of effect on inflammatory activity was expected, the researchers noted.
“These data are impressive. But the results say that RANKL inhibition can be adjunctive therapy to protect bone, but would not be a replacement for existing anti-inflammatory, disease-modifying, or biologic therapy, primarily because denosumab has no effect on ACR20/50/70 or DAS28 scores,” Cush noted.
Adverse events were similar across the groups, with rates of hypocalcemia and fracture being comparable. Serious adverse events were reported in 5.8% of the placebo group and 8.6% of both denosumab groups, although stomatitis occurred more often in the denosumab groups. One patient in the 3-month group died of interstitial lung disease, which was considered drug related although the patient also had rheumatic interstitial pneumonia.
“We believe that this drug is a novel treatment option for patients with RA who do not respond well to conventional synthetic DMARDs, are unable to adjust or start other DMARDs due to safety concerns or costs, or require treatment for osteoporosis,” Takeuchi and colleagues concluded.
A limitation of the study was its short duration.
The trial was sponsored by Daiichi Sankyo.
The authors reported financial relationships with multiple companies including Amgen, Daiichi Sankyo, AbbVie, Asahi Kasei, Astellas, Chugai, Eisai, Mitsubishi Tanabe, Novartis, Pfizer, Takeda, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Sanofi, UCB, Merck Sharp & Dohme, Teijin, Boehringer Ingelheim, Celgene, and Nippon Shinyaku.
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CAR T-Cell Therapy Emerges in Multiple Myeloma

A novel chimeric antigen receptor (CAR) T-cell therapy induced complete and durable responses in a phase I trial involving patients with heavily pretreated multiple myeloma.
Of 33 patients treated with bb2121, a B-cell maturation antigen (BCMA)-directed product, 85% achieved an objective response, reported James N. Kochenderfer, of the National Cancer Institute in Bethesda, Maryland, and colleagues.
And the agent induced complete and stringent complete responses in 9% and 36%, respectively, they wrote in the New England Journal of Medicine.
“The exciting thing with what was reported with bb2121 is that patients truly are having deep responses,” Sarah Holstein, MD, PhD, of the University of Nebraska Medical Center in Omaha, told MedPage Today. “For many of these patients these responses lasted an average of about a year.”
Median duration of response was 10.9 months in the study, progression-free survival (PFS) was 11.8 months, and all responders who could be evaluated for minimal residual disease (MRD) reached MRD negativity.
Holstein, who was not involved in the research, said the study provides the “first benchmark” for CAR T-cell therapy in multiple myeloma. “From now on, all future CAR T-cell studies are going to refer to this.”
And she noted that other trials of active agents in patients with heavily pretreated disease have yielded response durations “best measured in the 3- to 6-month range,” and with responses not typically as deep as those in the present study.
To that point, the authors highlighted a study of single-agent daratumumab(Darzalex) with a response rate of 29% and median PFS of 3.7 months, as well as a study on pomalidomide (Pomalyst) plus dexamethasone that showed a response rate of 31% and median PFS of 4 months. Similarly, the FDA recently convened an advisory committee to review whether selinexor, an agent that combined with dexamethasone elicited responses in roughly 26% of pretreated myeloma patients, should receive regulatory approval.
Holstein said the next step will be to see if CAR T-cell therapies in earlier lines of myeloma therapy will result in even better responses for patients than current approaches (studies in these settings are ongoing with bb2121 and another BCMA-targeting CAR T-cell agent).
“The million dollar question — or perhaps more, given the cost of these drugs — is really the durability of these responses,” she said. “At this point it’s too early to say that patients are being cured, but even if we can get patients several years’ worth of treatment-free time, that would be an incredible thing for this field.”
Study Details
From 2016 to 2018, the open-label phase I study enrolled 36 patients with relapsed or refractory multiple myeloma at centers across the U.S. who then underwent leukapheresis. Eligible patients had to have been treated with a minimum of three previous lines of therapy, including an immunomodulatory agent and a proteasome inhibitor, but most were far more heavily pretreated than that — median of 7 prior therapies in the dose-escalation group and 8 in an expansion cohort. All patients had been exposed to bortezomib (Velcade) and lenalidomide (Revlimid), and 91%, 94%, and 92% had exposure to carfilzomib (Kyprolis), pomalidomide, and daratumumab, respectively.
The CAR T-cell therapy was successfully manufactured in all patients, but three experienced disease progression prior to the infusion and were unable to receive bb2121.
“Sometimes the problem with CAR T-cell therapy is the amount of time that it takes between collecting the patients’ cells and then finally re-infusing them, and sometimes the myeloma can’t be controlled and patients get too sick to then receive the product,” said Holstein. “Overall, the majority of patients who enrolled in the study in fact received CAR-T therapy, which is a really important point.”
Grade 3/4 adverse events (AEs) were mostly hematologic in nature and included neutropenia (85%), leukopenia (58%), thrombocytopenia (45%), and anemia (45%). Cytokine release syndrome occurred in 76% of patients but were mostly grade 1/2 (70%). Two grade 3 cases (the remaining 6%) resolved within 24 hours. Grade 1/2 neurologic toxicity occurred in 39% of patients, and one reversible grade 4 neurologic event was reported in a patient 11 days post-infusion.
“Although comparisons among studies are complicated by differences in patient populations, CAR constructs, administered doses, and grading scales of toxic effects, the results observed with bb2121 indicate a favorable safety profile,” the authors wrote.
“There really were no alarming off-target toxicities that were seen — that’s always a concern because the cellular therapy is so effective,” said Holstein. “Even though BCMA is expressed on plasma cells, there’s always the concern that very low expression in other tissues could be affected by the CAR-Ts, but certainly there’s no indication of that here.”
Prior to the single CAR-T infusion, patients underwent lymphodepletion with fludarabine and cyclophosphamide. During the dose-escalation phase of the study, patients were given CAR T-cell doses ranging from 50×106 to 800×106. During the expansion portion of the trial, doses ranged from 150×106 to 450×106. In all, most patients received the 450×106 dose (n=19). Complete responses were seen in all doses of 150×106 and above. At data cutoff, six of the 15 complete responders had relapsed.
Tumor BCMA expression did not appear to have an impact on treatment response, the authors noted. At the 450×106 dose, response rates were similar among patients with tumor BCMA expression levels below 50% and in those with expression levels of 50% and above.
BCMA “is a member of the tumor necrosis factor superfamily of proteins that is primarily expressed by malignant and normal plasma cells and some mature B cells, making it a potential target for multiple myeloma,” Kochenderfer’s team explained.
Holstein said that since BCMA has been identified as a target in multiple myeloma, the CAR T-cell therapy field has moved along quickly. Current FDA-approved CAR T-cell therapies — such as those for diffuse large b-cell lymphoma and acute myeloid leukemia — target CD19, but myeloma cells really don’t express CD19, she said.
The study was funded by Bluebird Bio and Celgene.
Kochenderfer reported relationships with Celgene, Kite/Gilead, and disclosed patents related to BCMA targeting CAR T-cell therapy. Co-authors disclosed relationships with other industry entities and several are employed by either Bluebird Bio or Celgene.
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Nanofiber-hydrogel composite allows soft tissue to regenerate

 Nanofiber-hydrogel composite allows soft tissue to regenerate


Electron microscope images comparing native fat tissue in rats (B) to the nanofiber-hydrogel composite material (C). Credit: X. Li et al., Science Translational Medicine (2019)
A team of researchers at Johns Hopkins School of Medicine has developed a gel that, when injected into test animals, allowed new soft tissue to grow—replacing lost tissue. In their paper published in the journal Science Translational Medicine, the group describes their work developing the gel and how well it worked in test rats and rabbits.
When a person loses a chunk of soft due to an accident, infection or , surgeons have very few options available to induce the body to regenerate the missing tissue, leaving patients with disfiguring reminders of their loss. In this new effort, the researchers have developed a new gel that shows promise as a soft-tissue regenerative tool.
To make the gel, the team created nanofibers using a polymer that was known to biodegrade easily. It has been used for several years in real medical applications. Next, the nanofibers were treated to allow some of them to bind with —it, too, has been used in real medical applications—in this case, to create gels that promote infiltration by macrophages, which leads the body to create blood vessels. The result was an easily injectable gel that could serve as a scaffolding that also promotes regeneration of lost soft tissue. The researchers note that the gel was very close in feel to real tissue, both resilient and soft.
The researchers tested their gel by removing tissue from lab rats and rabbits and then filling the cavities with the gel. They report that the gel very easily conformed to the shape of the cavity before it firmed up. But more importantly, macrophages appeared and began infiltrating the gel and sending out signals that induced the body to create new cells and blood vessels inside the gel as it biodegraded. The end result was regeneration of lost tissue. The researchers note that the gel assisted in regenerating missing soft tissue up to 10 cubic centimeters, which, they further note, is about the size of a human finger. Clinical trials to test the new gel in humans could come very quickly, as all of the ingredients are already used in other medical applications.



Explore further
More information: Xiaowei Li et al. Nanofiber-hydrogel composite–mediated angiogenesis for soft tissue reconstruction, Science Translational Medicine (2019). DOI: 10.1126/scitranslmed.aau6210
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