Reimagining Cell Therapy Through the Untapped Potential of Fibroblasts
By: Vera Kovacevic, PhD
Interviewees: Pete O’Heeron, Chairman, CEO and Founder, FibroBiologics; and Hamid Khoja, PhD, CSO, FibroBiologics
Reimagining Cell Therapy Through the Untapped Potential of Fibroblasts
By: Vera Kovacevic, PhD
Interviewees: Pete O’Heeron, Chairman, CEO and Founder, FibroBiologics; and Hamid Khoja, PhD, CSO, FibroBiologics
While stem cells and CAR-T therapies have dominated cell-based research headlines for over a decade, one Houston-based biotech believes another cell type could quietly transform the field.
FibroBiologics, a clinical-stage biotech company, is investigating the use of fibroblast cells as therapeutic agents to treat chronic diseases ranging from multiple sclerosis (MS) and degenerative disc disease to wound healing, cancer and even age-related immune decline.
Leading this effort are Pete O’Heeron, Founder, Chairman and CEO, and Dr. Hamid Khoja, the company’s Chief Scientific Officer.
Together, they’ve built one of the world’s largest intellectual property portfolios focused on fibroblast-based therapeutics, with more than 270 patents and applications. They’re advancing the first clinical program designed to bring these cells from the lab to the clinic.
“There are two main types of cells you can use to treat chronic disease and regenerate tissue: stem cells, which everyone’s heard of, and fibroblasts, which almost no one has heard about in a therapeutic context,” O’Heeron said. “We’ve found fibroblasts to outperform stem cells in every head-to-head test. They’re easier to harvest, easier to grow and far more stable.”
Why Fibroblasts May Outperform Stem Cells
Fibroblasts are the body’s most abundant connective tissue cells, responsible for producing extracellular matrix proteins such as collagen and fibronectin that maintain structural integrity and promote healing.
Unlike stem cells, which have been shown to spontaneously differentiate, fibroblasts are fully differentiated and highly resilient under culture conditions, enabling reproducible manufacturing and consistent therapeutic output.
As O’Heeron and Khoja detailed in a recent article comparing fibroblasts and stem cells, the two share several surface markers and regenerative capabilities, yet fibroblasts demonstrate greater stability, faster proliferation and easier scalability for therapeutic use.
O’Heeron explained this distinction with characteristic clarity: “Stem cells are inherently unstable; they want to be anything other than what they are. Fibroblasts, on the other hand, are stable, fully differentiated and durable. You can harvest them from a small skin biopsy and generate hundreds of thousands of doses from that single sample.”
FibroBiologics’ research suggests that fibroblasts combine the regenerative and immune-modulatory benefits of mesenchymal stem cells (MSCs) with superior scalability, stability and cost efficiency. The company’s early studies indicate that fibroblasts not only survive better in culture but also maintain their normal characteristics even after many rounds of expansion, a crucial factor for clinical-grade manufacturing.
Lessons from Early Studies: Potency, Stability and Novel Formulations
As the first team to potentially use fibroblasts therapeutically, FibroBiologics has had to chart new territory in both science and process development.
“Everything we’re doing is brand new,” said Khoja. “We’re learning new lessons every day.”
One of the team’s key innovations lies in delivering fibroblasts as three-dimensional spheroids rather than single-cell suspensions. “We’ve found that when fibroblasts are administered in spheroid form, they elicit a much lower immune response, exactly what you want from a therapeutic cell,” Khoja explained. “You don’t want the immune system attacking the cells you’re introducing.”
The company has also optimized methods to differentiate fibroblasts into other cell types, such as chondrocytes (cells critical for cartilage repair), in as little as three days. “We hope to fine-tune that process to produce a therapeutically usable product very quickly, and we’ve secured patent protection on that capability,” Khoja added.
Perhaps one of the most intriguing findings involves the role of fibroblasts in human longevity. FibroBiologics has developed organoids containing fibroblasts that restore thymic function, enabling the production of new T-cells in animal models. The company is progressing this technology toward clinical development.
“By your sixties, you’ve lost about 90% of your thymic function,” Khoja said. “When that happens, your immune system no longer recognizes or destroys cancer cells effectively. By stabilizing organoids with fibroblasts, we’ve been able to recover that lost immune functionality.”
“Most people associate fibroblasts with fibrosis or scarring. But as more publications emerge on their regenerative and immune-regulating roles, people are starting to see their therapeutic potential.”
— Hamid Khoja, PhD, CSO, FibroBiologics
“Most people associate fibroblasts with fibrosis or scarring. But as more publications emerge on their regenerative and immune-regulating roles, people are starting to see their therapeutic potential.”
— Hamid Khoja, PhD, CSO, FibroBiologics
Manufacturing at Scale: From CDMO to In-House GMP Plans
As fibroblast-based therapies advance toward clinical testing, manufacturing remains a critical focus. FibroBiologics has partnered with a CDMO to produce its first clinical batches, including spheroid formulations, for an upcoming Phase I/II trial in diabetic foot ulcers planned for early 2026.
“This is the first time a CDMO has manufactured fibroblast spheroids for therapeutic use,” Khoja noted. “It’s been challenging, but our partners have been instrumental in helping us optimize the process.”
The company’s long-term goal is to bring manufacturing in-house within its Houston facilities, which have been designed with GMP capabilities in mind.
“Once the diabetic ulcer trial concludes, we plan to expand internal production for our other clinical programs,” said Khoja. “Full control over manufacturing will allow us to ensure quality, consistency and scalability as we move into additional indications.”
Translating Fibroblast Science into Multiple Clinical Applications
FibroBiologics views fibroblast therapy not as a single treatment, but as a platform technology capable of generating multiple therapeutic verticals. “We’re not only developing platforms, we’re developing platforms inside a platform,” O’Heeron explained.
For example, the company’s wound care program begins with diabetic foot ulcers but is expected to expand to other chronic and post-surgical wounds, burn injuries and perhaps even consumer wound-healing products.
“Eventually, you may see this technology in over-the-counter bandages that help wounds close faster and heal better,” O’Heeron said.
Beyond wound healing, FibroBiologics is developing programs for degenerative disc disease and orthopedic applications, alongside its human longevity platform that focuses on immune rejuvenation through thymic organoid restoration.
“Hamid’s team is working on exciting early-stage orthopedic research,” O’Heeron added. “Each of these represents a platform in itself.”
The Path to the Clinic: Immune Modulation and Chronic Disease
Dr. Khoja sees fibroblasts making their first major impact in chronic diseases driven by immune dysfunction. “Our data show that these cells are potent immune modulators,” he said.
“They help bring the immune system back into homeostasis, which can reduce chronic inflammation and support the body’s natural regenerative processes.”
This dual effect of modulating immune activity while promoting tissue repair positions fibroblast therapy as a potential disease-modifying approach for conditions such as MS, psoriasis, rheumatoid arthritis and type 1 diabetes.
Looking ahead, Khoja envisions fibroblast-based treatments not only for managing chronic inflammation but also for preventing its onset in at-risk populations.
“If you can stabilize immune regulation early,” he said, “you may be able to prevent cardiovascular, renal and hepatic diseases before they manifest.”
“We’ve found fibroblasts to outperform stem cells in every head-to-head test. They’re easier to harvest, easier to grow and far more stable.”
— Pete O’Heeron, Chairman, CEO and Founder, FibroBiologics
“We’ve found fibroblasts to outperform stem cells in every head-to-head test. They’re easier to harvest, easier to grow and far more stable.”
— Pete O’Heeron, Chairman, CEO and Founder, FibroBiologics
Redefining the Cell Therapy Landscape
Both O’Heeron and Khoja believe fibroblasts could fundamentally reshape the cell therapy field.
“Stem cells have potential, but they’ve turned out to be far more difficult to manufacture and scale than people expected,” said Khoja. “Fibroblasts don’t have those limitations.”
O’Heeron agreed, noting that the simplicity, stability and potency of fibroblasts could enable widespread clinical adoption. “You’ve only seen one stem cell product reach approval in recent years, and that’s because of instability and complexity,” he said. “Fibroblasts are robust, consistent and cost-effective. They can shape the next decade of cell-based therapeutics.”
As awareness grows, the team hopes the field will begin to recognize fibroblasts not merely as structural support cells but as active therapeutic agents capable of influencing immunity, regeneration and longevity.
“Most people associate fibroblasts with fibrosis or scarring,” Khoja said. “But as more publications emerge on their regenerative and immune-regulating roles, people are starting to see their therapeutic potential.”
The Next Chapter in Cell Therapy Innovation
With 270+ patents, multiple therapeutic platforms and first-in-human studies on the horizon, FibroBiologics is driving progress at the intersection of cell biology and clinical translation.
By unlocking the therapeutic potential of fibroblasts, which are the body’s most abundant cells in connective tissue, the company aims to make regenerative medicine more stable, scalable and accessible for chronic diseases that have long lacked durable solutions.
As O’Heeron put it, fibroblasts “actually began the entire stem cell revolution,” and today, they may be poised to lead a new one of their own.
ABOUT Pete O’Heeron
Pete O’Heeron is one of the most preeminent biopharma inventors of his generation, with over 350+ patents issued and pending in the areas of biologics, cell therapy and medical devices. Mr. O’Heeron is Chief Executive Officer of FibroBiologics and a seasoned leader in his field, comprising over 25 years of experience in medical technology and biotech development. As CEO, he has positioned FibroBiologics to become a global leader in fibroblast-based cell therapies with the development and commercialization of therapies that can cure and treat patients suffering from chronic diseases. He brings together multi-disciplinary teams and resources necessary to commercialize unique technologies and currently holds 350+ patents issued/pending.
Prior to founding FibroBiologics/FibroGenesis, LLC, he founded an operational investment group, Advanced Medical Technologies, LLC, that identified early-stage opportunities in the medical field with strong intellectual property potential. He also founded NeoSurg Technologies that developed the T2000 Minimally Invasive Access System. The sale of NeoSurg Technologies to Cooper Surgical occurred in 2006.
He brings decades of executive-level experience at Christus Health Care Corporation and strategic advisory to healthcare companies in the areas of biologics, advanced surgical instrumentation and telemedicine to his company, along with an academic foundation rooted in healthcare administration. He received his Bachelor’s degree in Healthcare Administration at Texas State University, his Masters in Healthcare Administration from the University of Houston Clear Lake and his Executive Management Certification in Mergers and Acquisitions from University of Chicago.
ABOUT Hamid Khoja
Hamid Khoja, PhD, joined FibroBiologics as Chief Scientific Officer in August 2021. He leads all research, development and advancement for the pipeline of cell therapy candidates. He has more than 25 years of experience as a leader of scientific teams, development of cell-based genomic, proteomic and epigenetics assays, and tools, protocols and technologies for use in drug discovery and development and clinical diagnostics.
He has distinguished himself with six patents issued/pending and 27+ peer-reviewed published papers.
He most recently served as the Principal Scientist at Covaris, a privately held scientific tools company with emphasis in genomics, epigenetics and proteomics. He provided long-term strategic applications proposals to the CEO, managed external collaborations for product and applications development, assessed new technologies for acquisition and OEM opportunities and presented posters and presentations at numerous scientific conferences. He led the effort in successfully incorporating Covaris technology into the Illumina Next Generation Sequencing technology protocols, leading to over 15,000+ citations. He also developed the Covaris chromatin immunoprecipitation methodology with 3,000+ citations in peer-reviewed publications and positioned Covaris technology to be used for simplifying epigenetics assay workflows for use in drug development and discovery and clinical use. He led collaborations with NCI for successful development of microbiome DNA extraction using acoustics and the completion of FDA EUA SARA-CoC-2 bridge study design for approval of new sample collection and viral RNA extraction using Covaris technology. He developed a patented workflow for the manufacturing of synthetic cell-free DNA for use as reference standard in sequencing-based liquid biopsy clinical oncology-based assays.
Prior to Covaris, he was a scientist at Genomic Solutions, a startup scientific tools company later acquired by Harvard Apparatus. There, he led the development of a high-throughput protein crystallization platform used in the pharmaceutical industry for drug development, managed the scientific applications group, presented company resources at scientific meetings and assessed new technologies for acquisition and OEM opportunities.
At the startup phase of Sequenom, he established the methodology for a highly multiplexed PCR used in the development of Sequenom’s massEXTEND technology for MALDI-TOF MS-based analysis of single nucleotide polymorphisms and genetic disease. As a scientist for the company, he led the effort in developing diagnostic MS-based assays for hemochromatosis, cystic fibrosis and 10 predominantly Jewish genetic diseases using Sequenom’s massEXTEND technology, which were then transferred to a large clinical diagnostic company.
During his career at Eli Lilly as a scientist, he established a high-throughput PCR and sequencing strategy using a variety of sequencing strategies and bioinformatic tools available in 1999 for obtaining high-coverage genome sequencing, which led to the finalization of the first ever complete sequence of the S. pneumoniae genome.
At Chiron Corporation, subsequently acquired by Novartis, he served as a scientist and helped in the design, development and optimization of HTP- binding assays for FGFR, VEGF, PDGF and EPO receptors. He also helped in the identification of novel g-protein coupled seven transmembrane receptors, novel proteins involved in the TNF signaling pathway and development of branched-DNA based HTP screening for ligand-induced oncogene quantification.
He graduated magna cum laude with a Bachelor of Science in Molecular Biology from the University of Southern California and a PhD in Molecular Biology from Boston University.