Houston biotech company gets FDA greenlight to move forward with COVID-19 stem cell treatment

coronavirus cure?

Celltex is looking into using stem cells to treat COVID-19, and the Houston biotech company just got the green light to go to trials. Photo courtesy of Celltex

A Houston-based biotech company announced last week that it has gotten the approval it was seeking from the U.S. Food and Drug Administration to continue testing its COVID-19 treatment that uses stem cells.

Celltex has received approval from its Investigational New Drug application, or IND, to look into stem cells — specifically Autologous Adipose Tissue-Derived Mesenchymal Stem Cells, or AdMSCs — and their effect on COVID-19 patients.

"The FDA's approval of our IND is not only a critical milestone for Celltex, but also for everyone who has been affected by COVID-19," says David G. Eller, Celltex chairman and CEO. "I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come."

Celltex has been in the stem cell business for nearly a decade and has treated patients with debilitating diseases like multiple sclerosis, Parkinson's, rheumatoid arthritis, and more. Eller says he's been considering how Mesenchymal Stem Cells, or MSCs, could be used amid the pandemic.

"Throughout the entire pandemic, MSCs have shown promise for combatting symptoms and complications associated with COVID-19, and as the nation's leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial," Eller says.

The FDA clearance will allow for a phase two trial "that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19," according to the release. There will be 200 patients across multiple centers that will be involved in the placebo-controlled study.

Celltex offices out of the Galleria area and has laboratory operations of its wholly-owned Mexican subsidiary are located in Hospital Galenia in Cancún, Quintana Roo, Mexico. Last year, Celltex planned an expansion into Saudi Arabia and also has a presence in Europe.

With the Texas Medical Center in their backyard, these Houston biotech companies are creating breakthrough technologies. Getty Images

5 Houston biotech companies taking health care to new levels

The future is now

Houston is the home of the largest medical center in the world, so it comes as no surprise that the Bayou City is also home to breakthrough technologies. Here are five Houston companies developing some of this biotech advancements.

Moleculin Biotech Inc.

Houston-based Moleculin has three different oncology technologies currently in trials. Getty Images

Immunotherapy and personalized medicine get all the headlines lately, but in the fight against cancer, a natural compound created by bees could beat them in winning one battle.

In 2007, chairman and CEO Walter Klemp founded Moleculin Biotech Inc. as a private company. The former CPA had found success in life sciences with a company that sold devices for the treatment of acne. That introduction into the field of medical technology pushed him toward more profound issues than spotty skin.

"Coincidentally, the inventor of that technology had a brother who was a neuro-oncologist at MD Anderson," Klemp recalls.

The since-deceased Dr. Charles Conrad slowly lured Klemp into what he calls the "cancer ecosphere" of MD Anderson. In 2016, the company went public. And it looks like sooner rather than later, it could make major inroads against some of the toughest cancers to beat. Read the full story here.

Cavu Biotherapies

Dr. Colleen O'Connor has adapted immunotherapy treatments to be used in dogs. Courtesy of CAVU Biotherapies

Breakthrough biotech doesn't have to just be for humans. More than three years after its founding, Houston-based veterinary biotech company CAVU Biotherapies' had its first cancer patient: a black Labrador in Pennsylvania diagnosed with B-cell lymphoma.

Dr. Colleen O'Connor, CEO and founder of CAVU Biotherapies, established the company in July 2015 with a goal to help pets live longer post-cancer diagnoses. O'Connor, who earned a PhD in toxicology with a specialty in immunology, has more than a decade of hands-on experience researching cancer treatments.

"Our goal is to scale up and be able to increase our dogs' qualities of life with us," O'Connor said. "We want to keep families intact longer and we want to be able to modernize cancer care for our animals." Read the full story here.

Innovative Biochips

iBiochips, led by founder Lidong Qin, was awarded a $1.5 million grant in September to help develop a new technology that delivers data about the cell's genetic makeup and reports abnormalities. Courtesy of Lidong Qin

Innovative Biochips, a Houston-based biotechnology company, is one step closer to commercializing technology that the company hopes will provide an opportunity for researchers to detect diseases earlier.

The company was founded three years ago by Dr. Lidong Qin, a professor at the Houston Methodist Research Institute's department of nanomedicine. He launched iBiochips as an independent faculty startup that licensed technology from Houston Methodist. Qin says he wanted to engineer and manufacture devices that focus on revolutionizing single-cell isolation and genetic analysis. Read the full story here.

Celltex

Celltex's stem cell technology has received positive results from its multiple sclerosis, Parkinson's, and rheumatoid arthritis patients. Courtesy of Celltex

A Houston stem cell company is making strides in regenerative medicine. Celltex's treatment has been proved effective with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

David Eller, chairman, co-founder and CEO of the company, also recently announced the company's expansion to Saudi Arabia. Read the full story here.

Ridgeline Therapeutics

Houston-based Ridgeline Therapeutics isn't going to allow you beat aging, but someday it may well help you to live without muscle loss or diabetes. Getty Images

Stan Watowich pictures a world where elderly people have the same healthy muscles they had at a younger age. Watowich is CEO of Ridgeline Therapeutics, a spin-off company of the University of Texas Medical Branch in Galveston where he is an associate professor of biochemistry and molecular biology, and he wants to make it clear that he is not going to cure aging.

"You and I are still going to get old," he says. "But we have our hopes that as we get old our muscles will stay healthy."

He's talking about the drug candidate, RLT-72484. It has been shown to reactivate muscle stem cells and regenerate skeletal muscle in aged laboratory mice. Read the full story here.
This week's storites of those of entrepreneurship and opportunity. Getty Images

5 most popular innovation stories in Houston this week

Now trending

Editor's note: This week's top trending stories are those of entrepreneurship — a cryotherapy chain and a fitness-focused app, both born here with big growth plans — and opportunities — a biotech company expanding overseas and networking events to attend. Here's what InnovationMap readers were reading this week.

Houston-based cryotherapy chain grows its national presence

Houston-based iCRYO has a few Texas franchise locations expected to open in 2019,and more coming nationwide. Courtesy of iCRYO.

A Houston entrepreneur has taken his cryotherapy and wellness brand and franchised it from its origin in League City to upstate New York. But, that's only the beginning. The brand, iCRYO, currently has four locations in the Houston area and one in New York, and has four more coming to the Dallas-Fort Worth area, Austin, and another upstate New York location. But that's only the start, says co-founder and COO, Kyle Jones. To read the full story, click here.

Houston biotech company plans expansion into Saudi Arabian market

Saudi Arabian representatives met at Houston-based Celltex Therapeutics Corp.'s office earlier this month to finalize a memorandum of understanding. Courtesy of Celltex

A Houston company that uses stem cell technology to treat patients suffering from degenerative diseases is taking its patented technology to another continent. Celltex Therapeutics Corp. has entered a memorandum of understanding with Saudi Arabia's Research Products Development Company. As a part of the partnership solidified by the MOU, Celltex will open an office in Riyadh, Saudi Arabia, later this year. The new office will aid the commercialization of Celltex's technology and expand the company's presence to Saudi Arabia. To read the full story, click here.

Houston entrepreneurs aim to connect fitness fiends around the city through a mobile app and curated events

Through the Houston-based Muvve app, fitness fans can meet each other on the app or at curated events around town. Courtesy of Muvve

When Avi Ravishankar decided to train for a marathon in high school, he wanted to find a training buddy. He got lucky, and one found him: his classmate, Julian Se, took on the task. Usually, finding fitness friends and training buddies isn't that easy — especially in a huge, spread out city of Houston. Ravishankar and Se turned their friendship into a business partnership to solve this problem. Houston-based Muvve is a mobile app that's mission is to connect fellow fitness enthusiasts across the city. The two came up with the idea as a way to merge their passions. To read the full story, click here.

10 can't-miss Houston business and innovation events for March

From startup competitions to thought-provoking panels, here's where you need to be in March. Getty Images

Rodeo has kicked off and spring break is around the corner, which can only mean one thing: March in Houston. The month is chock full of business, entrepreneurial, and innovation-focused events, but we've plucked out 10 to highlight this month. To read the full story, click here.

4 health-focused Houston innovators to know this week

From cryotherapy and NASA-inspired fitness to startup funding and biotech, this week's innovators to know are raising the bar on health tech and innovation. Courtesy photos

This week's innovators to know are focused on health and wellness, from a Houston-based cryotherapy franchise to the person behind funding medical device and digital health startups. We couldn't narrow these folks down to the usual three, so here are the four Houston innovators to know as we start the last week in February. To read the full story, click here.
Saudi Arabian representatives met at Houston-based Celltex Therapeutics Corp.'s office earlier this month to finalize a memorandum of understanding. Courtesy of Celltex

Houston biotech company plans expansion into Saudi Arabian market

On the move

A Houston company that uses stem cell technology to treat patients suffering from degenerative diseases is taking its patented technology to another continent.

Celltex Therapeutics Corp. has entered a memorandum of understanding with Saudi Arabia's Research Products Development Company. As a part of the partnership solidified by the MOU, Celltex will open an office in Riyadh, Saudi Arabia, later this year. The new office will aid the commercialization of Celltex's technology and expand the company's presence to Saudi Arabia.

"We are honored to forge a relationship with Saudi Arabia," says David G. Eller, CEO and chairman of Celltex, in a release. "Our collaboration with this first-rate global cohort furthers our commitment to initiating breakthroughs in regenerative medicine, and our presence in Riyadh will further expand our opportunities to improve the quality of life of those in need."

The MOU is a part of the country's effort to diversify the economy that's been dominated by oil and gas, the release says. As a part of Saudi Arabia's National Industrial Development and Logistic Program, Celltex and other United States companies were invited to Riyadh to sign MOUs in January, which resulted in billions of dollars in Saudi investment, per the release.

On February 4, the two parties reconvened at Celltex's office in Houston. The group included top Saudi dignitaries, Abdulmohsen Almajnouni, CEO of RPDC, as well as others.

"We are excited to explore business opportunities with Celltex, a biotechnology company with the innovative proprietary technology, patents and know-how for the cultivation and therapeutic application of stem cells," Almajnouni says in the release.

Celltex currently extracts patients' stem cells at various partner facilities across the United States, but implementation happens at a hospital in Mexico, due to FDA regulations and red tap. However, Eller doesn't foresee this being the process forever.

"We have very good relations with the US FDA," he says in an InnovationMap article. "They are very interested in what we know. Our approach is really is very progressive and we've grown every year."

The company's treatment has been proved effective with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.
From a locally sourced meal service company to stem cell research and a balance measuring device, this week's innovators are ones to know in the health industry. Courtesy photos

3 Houston health-focused innovators to know this week

Who's who

More and more Americans are focusing on their health, from eating right to experimenting with new treatments or devices. These three Houston innovators are riding the coattails of this health-focused movement with their startups. With advances in technology and the movement only growing faster and faster, you'd better keep your eye on these Houston innovators.

Marla Murphy, founder of The Blonde Pantry

Courtesy of The Blonde Pantry

Marla Murphy didn't feel like she was doing enough to promote health and wellness with her platform, The Blonde Pantry. So, she expanded it to incorporate locally sourced produce and easy-to-make recipes she gets ready every weekend to deliver to her members by Monday.

"It's not about selling meals and moving on, I want this to be a lifestyle company that is really founded and has deep roots in Houston," says Murphy in a InnovationMap story.

Murphy tells InnovationMap that in the next year she hopes to expand into the retail space and find a bigger commercial kitchen to function as their own. She also hopes to partner with companies outside of food and continue to nourish lives in someway.

David Eller, chairman, co-founder and CEO of Celltex

Courtesy of Celltex

Stem cell treatment is personal to David Eller, chairman, co-founder and CEO of Celltex. Eller had the treatment in hopes of resolving pain from a college football injury.

"I would go to work and put four to six Advil in my pocket," Eller says in an InnovationMap story about Celltex's technology. Within months, he stopped needing those pills.

Houston-based Celltex tracks its progress with its patients. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

Katharine Forth, founder and CEO of Zibrio

Courtesy of Zibrio

Katharine Forth has used a technology she developed with her colleague at NASA to measure balance in astronauts to create a device that any terrestrial human can now use from the comfort of their own homes.

"The machines typically used for balance measurement can be as large as a telephone booth, so we invented a new way to measure postural control using a much smaller mechanism that fit inside a moon boot," Forth says in an InnovationMap article about Zibrio, The Balance Company. Zibrio, The Balance Company.

Zibrio is now a finalist for the 2019 SXSW Pitch in the health and wearables category and will take its balance technology to the stage in March.

Celltex's stem cell technology has received positive results from its multiple sclerosis, Parkinson's, and rheumatoid arthritis patients. Courtesy of Celltex

Houston company uses stem cell technology to treat patients suffering from degenerative diseases

Regeneration nation

The medical community has former governor Rick Perry to thank for a major stride in regenerative medicine.

"He had just gotten elected for the last time and he wanted to leave a legacy. He was tired of people going to Japan or Germany when they needed stem cells," recalls David Eller, chairman, co-founder and CEO of Celltex.

That was 2011, the year that the former president of Dupont Pharmeceuticals-Europe and orthopedic surgeon Dr. Stanley Jones incorporated as Celltex. Perry got the law passed to make it legal to harvest his stem cells, and Jones implanted them while the governor was under the knife for a spinal fusion surgery.

Perry resigned from the Celltex board in 2017, but the truth is, the company no longer needed his clout. Just a year after its debut, the company had in excess of 200 clients, each paying a banking enrollment fee of $6,500. Now, there are close to 1,300.

From research to recovery
Eller is originally from Houston, and he says his hometown is the ideal home base for the company, with its access to the world's largest medical center. The Galleria-area office and lab employ 35 people, with about 50 workers worldwide.

Close to the same time that his friend Perry received his stem cells, Eller also had the treatment in hopes of resolving pain from a college football injury.

"I would go to work and put four to six Advil in my pocket," the CEO recalls.

Within months, all of them remained in his pocket.

But others have had even more dramatic results. Celltex checks in with patients three, six and nine months after their treatments to find out how they're doing. Eighty-three percent of multiple sclerosis patients have reported improvement of symptoms specific to their disease, as have 73 percent of Parkinson's sufferers. But the staggering fact is that 100 percent of 58 respondents with rheumatoid arthritis say they have benefited.

Implementation and the FDA
Celltex's chief scientific officer, Dr. Jane Young, co-authored a study of two severe juvenile rheumatoid arthritis patients whose conditions didn't respond to standard treatments. After trying stem cells, both reported marked improvement in autonomic nervous system and immune function.

Stem cells are gathered through a patient's fat, which can be extracted at any of the 80 facilities around the country that partner with Celltex. The fat is processed at the Houston lab, where processing takes 30 to 35 days.

"We have 15 billion cells in process each day," says Erik Eller, the company's vice president of operations, clarifying that some clients' cells grow faster than others'.

It takes 14 days to come out of cryostasis and leave the lab. From there, the stem cells travel to Hospital Galenia in Cancun, Mexico for implantation, since the FDA categorizes stem cells as a drug if they have expanded as they do at Celltex. That means that a patient cannot use his own stem cells in the United States without a clinical trial. To circumnavigate the red tape, Celltex has simply partnered with the luxurious Mexican hospital.

This is currently the company's biggest challenge, says David Eller, but one he expects to overcome.

"We have very good relations with the US FDA," he says. "They are very interested in what we know. Our approach is really is very progressive and we've grown every year."

Ultimately, Eller hopes to be able to implant stem cells in the United States. But the company's foreign growth is a good start. Celltex is now operating in the Bahamas and is hoping to add Australian extraction facilities sometime this year. They are also in negotiations with a team from Saudi Arabia interested in expanding Celltex to the Middle East.

Other goals for Celltex include improvements both in the realms of sales and revenue and streamlining and improving the safety and efficacy of treatment. Research collaborations with Baylor College of Medicine and Texas A&M will help with the company's medical credibility. This all may help to convince the FDA to allow the Celltex to get a biologics license, the final proof that it is not a drug company. But no matter how it's categorized, Celltex is growing exponentially as its cells.

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University of Houston designs device that instantly kills COVID-19

ZAPPING COVID-19

While the world rushes to find a COVID-19 vaccine, scientists from the University of Houston have found a way to trap and kill the virus — instantly.

The team has designed a "catch and kill" air filter that can nullify the virus responsible for COVID-19. Researchers reported that tests at the Galveston National Laboratory found 99.8 percent of the novel SARS-CoV-2 — which causes COVID-19 — was killed in a single pass through the filter.

Zhifeng Ren, director of the Texas Center for Superconductivity at UH, collaborated with Monzer Hourani, CEO of Medistar, a Houston-based medical real estate development firm, plus other researchers to design the filter, which is described in a paper published in Materials Today Physics.

Researchers were aware the virus can remain in the air for about three hours, which required a filter that could quickly remove it. The added pressure of businesses reopening created an urgency in controlling the spread of the virus in air conditioned spaces, according to UH.

Meanwhile, to scorch the virus — which can't survive above around 158 degrees Fahrenheit — researchers instilled a heated filter. By blasting the temperature to around 392 F, they were able to kill the virus almost instantly.

The filter also killed 99.9 percent of the anthrax spores, according to researchers.

A prototype was built by a local workshop and first tested at Ren's lab for the relationship between voltage/current and temperature; it then went to the Galveston lab to be tested for its ability to kill the virus. Ren says it satisfies the requirements for conventional heating, ventilation and air conditioning (HVAC) systems.

"This filter could be useful in airports and in airplanes, in office buildings, schools and cruise ships to stop the spread of COVID-19," said Ren, MD Anderson Chair Professor of Physics at UH and co-corresponding author for the paper, in a statement. "Its ability to help control the spread of the virus could be very useful for society."

Medistar executives are also proposing a desk-top model, capable of purifying the air in an office worker's immediate surroundings, Ren added.

Developers have called for a phased roll-out of the device, with a priority on "high-priority venues, where essential workers are at elevated risk of exposure — particularly schools, hospitals and health care facilities, as well as public transit environs such as airplanes."

The hope, developers add, is that the filter will protect frontline workers in essential industries and allow nonessential workers to return to public work spaces.

3 Houston innovators to know this week

who's who

Houston's innovation ecosystem continues to grow. Last week, a group of startup mentors formed a new program that's a masterclass for aspiring entrepreneurs. Plus, a Houston innovator is writing the book on inclusion while another has a new partnership with a medical device company.

Steve Jennis, co-founder of Founder's Compass

Steve Jennis, along with three other Houston entrepreneurs, have teamed up to create a program based on each of their expertise that provides a launch pad for aspiring startup founders. Photo courtesy of Steve Jennis

Steve Jennis, a founder and mentor within the Houston innovation ecosystem, was thinking about opportunities for aspiring entrepreneurs. While there are several accelerators within the ecosystem, they tend to be months-long programs that might require equity.

"A few months ago it struck me that maybe there was a gap in the market between the aspiring entrepreneur," says Jennis, "and the accelerator or incubator program."

Jennis tapped a few of his fellow founder-mentors to create Founder's Compass, an online masterclass for people who have a business idea but don't know what to do next. Read more about the new program.

Denise Hamilton, founder and CEO of WatchHerWork

Denise Hamilton is publishing a book that helps guide Black Lives Matter allies to make changes that will help them change the world. Photo courtesy of WatchHerWork

After developing a long career as a corporate executive, Denise Hamilton was fielding tons of requests to lunch or coffee to "pick her brain." While she loved helping to mentor young businesswomen, it was starting to become exhausting. "Frankly, there weren't enough hours in the day," she says on this week's episode of the Houston Innovators Podcast.

So, five years ago, she turned the cameras on and started a library of advice from female executives like herself and created WatchHerWork. The company evolved to more, and now she's focused on diversity and inclusion consulting and leadership — and, amid COVID-19 and the resurgence of the Black Lives Matter movement, she's particularly busy now. Stream the episode and read more.

Chris DuPont, CEO of Galen Data

Houston-based Galen Data, led by Chris Dupont, is collaborating with an Austin health device company on a cloud-based platform that monitors vital signs. Photo via galendata.com

Houston-based Galen Data Inc., which has developed a cloud platform for medical devices, and Austin-based Advanced TeleSensors Inc., the creator of the Cardi/o touchless monitor. Together, the two health tech companies are collaborating to take ATS's device and adding Galen Data's cloud technology.

Chris DuPont, co-founder and CEO, has led the company to meet compliance standards set by the U.S. Food and Drug Administration (FDA), the Health Insurance Portability and Accountability Act of 1996 (HIPPA), cybersecurity organizations, and others.

"We knew that our platform would be a great fit for Cardi/o," Chris DuPont, CEO of Galen Data, says. "Speed was critical, accentuated by the COVID-19 crisis. We were well positioned to address ATS' needs, and help those at-risk in the process." Read more about the innovative Texas partnership.

Houston health tech startup with at-home COVID-19 test teams up with Texas university for research

be aware

An ongoing medical phenomenon is determining how COVID-19 affects people differently — especially in terms of severity. A new partnership between a Houston-based digital health platform and Texas A&M University is looking into differences in individual risk factors for the virus.

Imaware, which launched its at-home coronavirus testing kit in April, is using its data and information collected from the testing process for this new study on how the virus affects patients differently.

"As patient advocates, we want to aid in the search to understand more about why some patients are more vulnerable than others to the deadly complications of COVID-19," says Jani Tuomi, co-founder of imaware, in a press release. "Our current sample collection process is an efficient way to provide longitudinal prospectively driven data for research and to our knowledge, is the only such approach that is collecting, assessing, and biobanking specimens in real time."

Imaware uses a third-party lab to conduct the tests at patients' homes following the Center for Disease Control's guidelines and protocol. During the test, the medical professional takes additional swabs for the study. The test is then conducted by Austin-based Wheel, a telemedicine group.

Should the patient receive positive COVID-19 results, they are contacted by a representative of Wheel with further instructions. They are also called by a member of a team led by Dr. Rebecca Fischer, an infectious disease expert and epidemiologist and laboratory scientist at the Texas A&M University School of Public Health, to grant permission to be a part of the study.

Once a part of the study, the patient remains in contact with Fischer's team, which tracks the spread and conditions of the virus in the patient. One thing the researchers are looking for is the patients' responses to virus complications caused by an overabundance of cytokines, according to the press release. Cytokines are proteins in the body that fight viruses and infections, and, if not working properly, they can "trigger an over-exuberant inflammatory response" that can cause potentially deadly issues with lung and organ failure or worse, per the release.

"We believe strongly in supporting this research, as findings from the field can be implemented to improve clinical processes-- helping even more patients," says Wheel's executive medical director, Dr. Rafid Fadul.

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