Based on promising results in an early clinical trial, Mayo Clinic has formed a new joint venture with materials engineering firm W.L. Gore & Associates to spearhead a new therapy using stem cells to repair a painful tissue problem stemming from Crohn's disease.
Mayo and Gore on Tuesday announced the formation of a for-profit company called Avobis Bio ("a vobis" is Latin for "by you"), based in Delaware, where Gore is also based. The privately held company will draw on the expertise of scientists at Mayo and Gore to launch a second-phase clinical trial in the hopes of eventually offering the treatment commercially.
A laboratory director at Mayo Clinic said Avobis Bio's therapy, if successful, may be a first-of-its-kind in health care, involving the delivery of a person's own mesenchymal stem cells on a synthetic "scaffold" that biodegrades over time, eventually leaving behind only native tissue sealing a wound. The first application of the technology is treatment of a health problem called perianal fistulae. But if successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials.
"This is a completely new approach, where we are trying to leverage what the body can do for itself," said Allan Dietz, co-director of the Human Cell Therapy Lab in Mayo's Center for Regenerative Medicine.
Mesenchymal stem cells can naturally convert into other kinds of tissue, like muscle or bone. For the Avobis Bio therapy, the cells are harvested from a biopsy of a person's body fat and cultivated at a Mayo laboratory to high purity. No one knows whether the cells deposited into the wound directly convert into scar tissue, or if the stem cells trigger genetic signals that cause other cells in the surrounding tissue to begin the healing process.
"We provide stem cells in the right frame, at the right time, for the body to recognize the signals that it should begin the healing process," Dietz said. "I think in some ways, it was a required simple first step but it appears to be a major step."
Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs. Mayo has used Gore-made devices for many years.
Several years ago, physician-researchers at the not-for-profit Mayo Clinic in Rochester grew keenly interested in a Gore device called the Bio-A Fistula Plug, a flexible bioabsorbable plug made from a material similar to dissolving stitches.
The plug can be used to repair unnatural canals that form between a person's anal canal and their outer skin, after Crohn's disease weakens surrounding tissues. These canals, also known as perianal fistulae, are painful, disruptive and difficult to treat, doctors said. For patients with Crohn's disease, lifetime incidence of perianal fistulae ranges between 23% and 38%, according to past studies.
In 2017, Mayo announced first-in-human results of their experimental therapy treating Crohn's patients' perianal fistulae using a Gore Bio-A Fistula Plug coated with the patient's own stem cells. The study, run in consultation with the Food and Drug Administration, provided the open-label treatment to a small group of patients whose fistulae had not responded to treatment for a median time of six years.
After initial results proved encouraging, the trial eventually enrolled 20 people. Of the 19 who remained in the trial for at least a year, 76% experienced healing of their fistulae, according to results announced by researchers but not yet published in a journal. If validated in a larger clinical trial, that rate of healing would be dramatically better than outcomes under existing treatments, the companies said.
"We have done work in the past looking at combining cells and materials. For us, the clinical trial results from Mayo were incredibly compelling," said Tiffany Brown, a Gore employee and general manager of Avobis Bio. "It is a challenge to translate how cells behave in the lab to how they will behave in patients. So having that proof in real patients really got the conversation going on how we could work together."
If the therapy is proved safe and effective in larger trials, Brown said about 50,000 Crohn's patients per year could be eligible to get it for perianal fistulae. Although Gore is phasing out general sales of its Bio-A Fistula Plug, the device will be supplied exclusively to Avobis Bio.
Mayo and Gore declined to reveal financial details for Avobis Bio, except to note that both parties are contributing to the limited-liability joint venture. The company has a five-member board of managers, with Mayo appointing two members and Gore appointing three.
- Global Stem Cell Market Poised for Strong Growth as Global Regenerative Medicine Market Poised to Reach US$45 billion by 2025 - P&T Community - February 28th, 2020
- Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update - BioSpace - February 28th, 2020
- Creative Medical Technology Holdings Inc (OTCMKTS: CELZD) Gets the Extra D - MicroCap Daily - February 28th, 2020
- If medications fail, surgery option for treating infectious retinitis - Ophthalmology Times - February 28th, 2020
- BTK Inhibitors Offer Improved Response Over Chemotherapy in Mantle Cell Lymphoma - Curetoday.com - February 28th, 2020
- Aspire Regenerative Medical Director Featured on New Podcast - PR Web - February 28th, 2020
- Global Regenerative Medicine Market Briefing 2020, Trends, Applications, Types, Research, Forecast To 2025 - Bandera County Courier - February 28th, 2020
- New study identifies trigger that turns dormant cancer stem cells into active ones - Yahoo Finance - February 27th, 2020
- Editas Medicine Announces Fourth Quarter and Full Year 2019 Results and Update - Yahoo Finance - February 27th, 2020
- On the Road to 3-D Printed Organs - The Scientist - February 27th, 2020
- Researchers have found a probable cure for diabetes and we need to thank diabetic lab mice for it - International Business Times, Singapore Edition - February 27th, 2020
- Kiadis Pharma announces FDA clearance of clinical study by The Ohio State University in R/R AML with off-the-shelf NK cells from universal donors -... - February 27th, 2020
- Immune-Based Therapies Emerge in Mantle Cell Lymphoma - Curetoday.com - February 24th, 2020
- Texas A&M Researcher Named To National List Of Inspiring Black Scientists - Texas A&M University - February 24th, 2020
- Locking in and preserving your healthy stem cells has never been easier and more accessible as Acorn Biolabs partners with Coverdale Clinics. - Canada... - February 22nd, 2020
- Chinese Scientist Unite Together to Tackle With COVID-19 - Benzinga - February 22nd, 2020
- Army spouse dances her way through chemotherapy - We Are The Mighty - February 22nd, 2020
- The Winnipeg Foundation Innovation Fund supports cutting-edge research - UM Today - February 22nd, 2020
- Locking in and preserving your healthy stem cells has never been easier and more accessible as Acorn Biolabs partners with Coverdale Clinics. - Yahoo... - February 20th, 2020
- Missouri S&T researchers create organ tissue with bioactive glass, stem cells and 3D printer - The Rolla Daily News - February 20th, 2020
- Regenerative Medicine Market trends, leaders, segment analysis and forecast to 2030 described in a new market report - WhaTech Technology and Markets... - February 16th, 2020
- 5 Aesthetic Clinics To Know In The Klang Valley & Their Signature Treatments - Malaysia Tatler - February 14th, 2020
- Tech Ventures kicks off series dedicated to supporting female inventors and entrepreneurs at Johns Hopkins - The Hub at Johns Hopkins - February 14th, 2020
- BrainStorm Cell Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Provide a Corporate Update - GlobeNewswire - February 11th, 2020
- CD229 CAR T-cell therapy treated tumours had lasting response mice - Drug Target Review - February 11th, 2020
- BrainStorm Cell Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Provide a Corporate Update - BioSpace - February 11th, 2020
- Early Findings Show Promise of CAR NK-Cell Therapy in Leukemia, Lymphoma - Cancer Network - February 9th, 2020
- Physical forces at the interface with biology and chemistry - PLoS Blogs - February 9th, 2020
- Scientists create 'Chemical gardens' that can be used as bone substitute materials - University of Birmingham - February 7th, 2020
- Lab-grown heart cells implanted into human patient for the first time - New Atlas - January 29th, 2020
- Engineer the future of human health with a PhD in biomedical engineering - Study International News - January 29th, 2020
- GIOSTAR Announces Medical Breakthrough in Biotechnology and Lifesciences To Manufacture Abundant, Safe Red Blood Cells From Stem Cells - Benzinga - January 29th, 2020
- Study suggests Parkinson's present from birth and may be preventable - New Atlas - January 29th, 2020
- Celavie Biosciences Presented Five-Year Follow-Up Data in Parkinsonian Patients at the World Stem Cell Summit - Yahoo Finance - January 22nd, 2020
- The Brave New World of Organoids - North Forty News - January 22nd, 2020
- The Tiny Brain Cells That Connect Our Mental and Physical Health - WIRED - January 22nd, 2020
- Organicell Regenerative Medicine Inc. Provides Update On Operations and Financial Reporting Status - GlobeNewswire - January 22nd, 2020
- Novel mutations in stem cells of young donors can be passed to recipients - BioNews - January 21st, 2020
- Gains in Stem Cell Transplant Mortality Over Last 25 Years - MedPage Today - January 21st, 2020
- Biomedical Applications of Zeolitic Nanoparticles, with an Emphasis on | IJN - Dove Medical Press - January 21st, 2020
- Cell therapy trialed in mice offers diabetes treatment hope - SelectScience - January 21st, 2020
- Scientists Image Heart RNA Structure for the First Time - Diagnostic and Interventional Cardiology - January 21st, 2020
- CAR T-Cell Therapy and Beyond: Off-the-Shelf Therapies Among Innovations at ASH 2019 - AJMC.com Managed Markets Network - January 21st, 2020
- Stem Cell Assay Market to Expand at a Healthy CAGR of XX% Between and 2017 2025 Dagoretti News - Dagoretti News - January 21st, 2020
- Introducing Generate Life Sciences - A First-Of-Its-Kind Company Focused On Helping Grow And Protect Healthy Families - Yahoo Finance - January 19th, 2020
- Editas Medicine and Sandhill Therapeutics, Inc. Announce Collaboration to Develop Engineered Cell Medicines to Treat Cancer - Yahoo Finance - January 19th, 2020
- Regenerative Medicine Market 2026: Product Approvals and Growing Pipeline of Regenerative Medicine P - PharmiWeb.com - January 18th, 2020
- Mutations in donors' stem cells may cause problems for cancer patients - Washington University School of Medicine in St. Louis - January 18th, 2020
- Global Cell Expansion Market by Type, Share Analysis, Top Players Eyeing to Penetrate Into Emerging Nations with Untapped Opportunities 2024 ... - January 18th, 2020
- Introducing Generate Life Sciences - A First-Of-Its-Kind Company Focused On Helping Grow And Protect Healthy Families - PRNewswire - January 18th, 2020
- Stem Cell and Regenerative Medicine Action Awards to be Presented at World Stem Cell Summit on January 23 at the Hyatt Regency Miami - GlobeNewswire - January 12th, 2020
- SNACS: The FAANG Of The Roaring 20s - Yahoo Finance - January 12th, 2020
- 20 Technology Metatrends That Will Define the Next Decade - Singularity Hub - January 12th, 2020
- LANL Scientists And International Partners Create 3-D Image Of Heart RNA Structure For First Time - My Blog - Los Alamos Daily Post - January 12th, 2020
- MicroCures Awarded $1.5M SBIR Grant To Support Development of Novel Therapeutic Platform for Accelerated Tissue Repair - BioSpace - January 8th, 2020
- 2020 Exosome Technologies Market Top Companies Analysis Including Capricor Therapeutics Inc, Evox Therapeutics Ltd, ReNeuron Group Plc, Stem Cell... - January 8th, 2020
- Gene editing breakthroughs that cured genetic diseases in 2019 - The Star Online - January 5th, 2020
- BrainStorm Cell Therapeutics Wins 2020 'Buzz of BIO' Award for ALS Investigational Therapy - ALS News Today - January 3rd, 2020
- Cell and Advanced Therapies Supply Chain Management Industry Report, 2019-2030 - GlobeNewswire - January 3rd, 2020
- miRNAs: A Promising Target in the Chemoresistance of Bladder Cancer | OTT - Dove Medical Press - January 3rd, 2020
- China confirms third birth of gene-edited baby; scientists involved get prison terms - WRAL Tech Wire - January 3rd, 2020
- Gene Therapies Make it to Clinical Trials - Discover Magazine - December 31st, 2019
- What is HLH, and what role did it play in the death of a healthy 34-year-old ESPN reporter? - FirstCoastNews.com WTLV-WJXX - December 29th, 2019
- 2019: The year gene therapy came of age - INQUIRER.net - December 29th, 2019
- Stem Cells Market is Expected to Expand at an Impressive Rate by 2023 - News Cast Report - December 29th, 2019
- ESPN reporter diagnosed with pneumonia, HLH. What is HLH? - Crossroads Today - December 27th, 2019
- 2019: the year gene therapy came of age - Times of India - December 27th, 2019
- This Is How Human Head Transplants Could Be Achieved, According To A Neurosurgeon - IFLScience - December 25th, 2019
- Taiwan Healthcare+ Expo 2019: A 360 exposure to MedTech and Therapeutic world - BSA bureau - December 22nd, 2019
- Lawmakers Present Mother & Daughter With the Signed Bill They Inspired - River Journal Staff - December 22nd, 2019
- Sorrento Announces Dr. Robin Smith as New Member of the Board of Directors - GlobeNewswire - December 22nd, 2019
- Association Between Change in Circulating Progenitor Cells During Exercise Stress and Risk of Adverse Cardiovascular Events in Patients With Coronary... - December 20th, 2019
- The Most Significant Cancer Research Advances of the 2010s - Dana-Farber Cancer Institute - December 20th, 2019
- Metabolic dysregulation: origins of neurodegenerative disease - Health Europa - December 20th, 2019
- Inside the US-Iran prisoner swap, and what comes next - Al-Monitor - December 20th, 2019
- Global Stem Cell Therapy Market to Surpass US$ 40.3 Billion by 2027 Coherent Market Insights - Business Wire - December 18th, 2019
- The 3D cell culture market is projected to reach USD 1,846 million by 2024 from USD 892 million in 2019, at a CAGR of 15.7% - PRNewswire - December 18th, 2019
- Orthopaedic Surgeon, Dr. Jeffrey Carlson, first in Central and Eastern Virginia to implant the M6-C Artificial Cervical Disc - BioSpace - December 18th, 2019
- Gene Therapy for Sickle-Cell Anemia Looks Promisingbut It's Riddled With Controversy - Singularity Hub - December 18th, 2019
- Orbiting Organoids: Research in Space to Unveil New Neurodegeneration Insight - Xconomy - December 18th, 2019