“…Frodo heard a sweet singing running in his mind: a song that seemed to come like a pale light behind a grey rain-curtain, and growing stronger to turn the veil all to glass and silver, until at last it was rolled back, and a far green country opened before him under a swift sunrise.”

-J.R.R. Tolkien, The Fellowship of the Ring  

It might come as a surprise to new readers, but RoosterBio’s cells, media, and bioprocess solutions have already been used to manufacture hundreds of patient doses in ongoing and completed clinical trials. Let’s take a step back and ask “why.” It starts with a dream of what lies beyond our reach, and then, a strong impulse to get there.

In Tolkien’s The Lord of the Rings, an impossible task was placed on Frodo, compelled to leave the comforts of his home in Bag End. Yet, early in his mission, he and his friends stumbled into the magical and mysterious Old Forest of Tom Bombadil. Exhausted from assorted encounters with Ringwraiths and malevolent willow trees, Frodo’s lulled by music older than the world itself, the Ainulindalë. This must have surely motivated him later, whilst clawing the slopes of Mount Doom. Everyone knows that on mythic quests, small hobbits and mighty warriors alike need transcendent epiphanies to see them through the land of shadows.

Another dream, no less sublime, is a call to restoration of wellness for all, a vision shared by RoosterBio as well as Rivendell’s venerable healers. As shown in this blog’s two examples, we enjoin our fellowship with those in search of novel regenerative cures, so that our partners can face a path far more de-risked and less obstructed than Frodo’s. We know that the translation from benchtop discoveries into bona fide clinical trials is a challenging crossing, even a “chasm” [A]  or a “valley of death.” We’d like to depict many more of these examples with you (and soon we will), but…we must deeply respect the confidentiality of our client relationships.

Now, let’s bring this vision down to earth with two real-world examples. RoosterBio was honored to support academic investigators who—like Frodo—ventured boldly despite needing to travel light and swift. RoosterBio was most fortunate to share a chapter in the Epic of Advanced Therapies with Dr. Ali Djalilian (U. of Illinois-Chicago) and Dr. Ashish Patel (King’s College London). As fate would have it, our regulatory and bioprocess chops could help armor and outfit their clinical and scientific expertise. The barriers facing these two clinicians are hardly unique: cost, GMP manufacturing, regulatory complexity, and scaling hurdles. However, despite not being privy to tens of $millions in cash-on-hand or billion-dollar market caps, they were able to make quick leaps of progress that many in biotech/pharma fail to consider.

Dr. Ali Djalilian: “Healing Sight with MSCs”

To learn more about this exciting work, please dive into a webinar [1] devoted to this topic, presented by Dr. Ali Djalilian, MD, and hosted by RoosterBio. This eye-opening lecture explored the potential of mesenchymal stromal cells (MSCs) and their secreted factors for treating corneal and ocular surface diseases, particularly in cases where traditional therapies fail. Corneal wounds that do not heal, such as those caused by neurotrophic keratitis, limbal stem cell deficiency, and chemical burns, pose significant clinical challenges, often leading to vision loss. The Djalilian Lab’s research investigates how MSCs and their extracellular vesicles (EVs) can promote epithelial healing, reduce inflammation, and regenerate corneal nerves. Preclinical studies in mice, rats, and rabbits demonstrated that subconjunctival injection of cryopreserved MSCs accelerated wound closure, confirming their safety, viability after thawing, and regenerative potential. [2]

To translate this work into clinical practice, Dr. Djalilian partnered with RoosterBio to develop a GMP-friendly MSC therapy that could be efficiently expanded and cryopreserved for patient use. A major challenge in bringing MSC therapies to the clinic is the need for consistent, high-yield cell expansion under regulatory-compliant conditions, which RoosterBio’s cell and media systems [3] helped overcome. This led to a Phase 1 clinical trial (NCT04626583) at the University of Illinois at Chicago, where patients with chronic corneal wounds received subconjunctival MSC injections at doses of 1, 3, or 6 million cells. Early results were highly encouraging, [4] showing rapid epithelial closure (within 1-8 weeks), improved corneal clarity, and no safety concerns. Given that MSCs may exert many of their effects through secreted factors instead of direct tissue integration, his team also explored the use of MSC-derived secretomes and exosomes as a potentially cell-free alternative. [5]

Building on these findings, Dr. Djalilian’s next steps included a Phase 1/2a trial (NCT05204329) to evaluate topical MSC-secretome eye drops, which could ultimately provide an off-the-shelf, scalable therapy for corneal regeneration. Additionally, his research is expanding into retinal diseases, glaucoma, and severe dry eye, where MSC-derived therapies may offer neuroprotective and anti-inflammatory benefits. [6] The webinar concluded with a discussion on how exosome-based therapies could replace traditional cell therapies, making regenerative medicine more accessible for ophthalmology and beyond.

Dr. Ashish Patel: Turning COVID-19 Crisis into Clinical Innovation for Fibrotic Lungs

Dr. Ashish Patel, MD’s webinar [7] detailed the rapid translation of his preclinical research into a first-in-human cell therapy trial for post-COVID-19 lung fibrosis. Initially focused on treating peripheral vascular disease (PVD), Dr. Patel had spent a decade studying monocytes and macrophages for their role in vascular regeneration. [8, 9, 10, 11, 12] His work showed that priming monocytes with mesenchymal stem cells (MSCs) could enhance their tissue-remodeling properties, promoting revascularization in ischemic limbs. However, during the COVID-19 pandemic, Dr. Patel observed that many recovered patients returned with severe lung function decline and fibrotic scarring, prompting him to pivot his research to address this urgent medical need. Recognizing that monocytes played a key role in lung repair, he sought to test whether his MSC-primed monocyte therapy could reverse lung fibrosis in these patients.

To rapidly translate this concept into a clinical trial, Dr. Patel faced a major manufacturing hurdle: he needed a large-scale, GMP-compliant source of MSCs to prime monocytes for patient treatment.  [13] Instead of developing a de novo MSC production process—which could take years—he turned to RoosterBio, whose off-the-shelf MSCs, backed by FDA regulatory documentation [14], enabled Dr. Patel’s team to immediately scale up production. This partnership allowed them to complete GMP technology transfer in just six weeks, bank 2 billion clinical-grade MSCs, and accelerate regulatory approvals, cutting down the typical timeline from two years to just eight months. With this infrastructure in place, Dr. Patel could focus on optimizing monocyte engineering and moving quickly into first-in-human testing.

The MONACO Phase 1 trial enrolled five patients with COVID-induced interstitial lung fibrosis, delivering their own MSC-primed monocytes intravenously. Early results were promising: no adverse events were reported, and most patients showed improved lung function, increased walking distance, and reduced fibrosis on CT scans. Encouraged by these findings, Dr. Patel is now expanding the trial into a Phase 1B/2A randomized, double-blind, dose-escalation study with 24 patients, using leukapheresis to collect more monocytes for higher-dose and repeated treatments. Beyond COVID-related fibrosis, Dr. Patel envisions this therapy being applied to other lung diseases and potentially back to vascular disease, [15] where it was initially developed. [8] His work highlights how academic-industry collaborations—particularly with RoosterBio—can accelerate cell therapy development for urgent medical needs.

Who Will Be Next?

The journey from scientific discovery to clinical impact is never straightforward. Like any great quest, it begins with profound inspiration to leave behind the comforts of the familiar. But then it must be followed by grit, the right tools, and trusted allies. Researchers like Drs. Djalilian and Patel didn’t wait for perfect conditions—they moved forward with urgency, backed by scalable solutions that turned obstacles into progress.

At RoosterBio, we believe the future of advanced therapies belongs to those who refuse to let the dark, Old Forest of uncertainty stop them. Even there, magic, and music and light can be found. Whether you’re at the beginning of your journey or facing the final hurdles before clinical translation, we’re here to guide you along… just like the helping hand of “ole’ Tom.”

 

References

1. Diamond, Julie. Bridging the Chasm Between Ideation & Commercialization for Advanced Therapy Startups: How to Build Support in the Early Days of Entrepreneurship. RoosterBio Blog 2023; Available from: https://www.roosterbio.com/blog/bridging-the-chasm-between-ideation-commercialization-for-advanced-therapy-startups-how-to-build-support-in-the-early-days-of-entrepreneurship/

1. RoosterBio. Translational Potential of hMSCs for Ocular Diseases. RoosterBio webinar 2022; Available from: https://share.hsforms.com/1AZ546MVwSdeKEg10uuNdYg3564o
2. Putra, I., et al., Preclinical Evaluation of the Safety and Efficacy of Cryopreserved Bone Marrow Mesenchymal Stromal Cells for Corneal Repair. Transl Vis Sci Technol, 2021. 10(10): p. 3. 10.1167/tvst.10.10.3
3. Snyder, Jessica, Carson, Jon. The Story Behind the Media. RoosterBio Blog 2022; Available from: https://www.roosterbio.com/blog/the-story-behind-the-media/.
4. Margolis, Mathew, et al., Phase I Study of the Safety of Locally Delivered Allogeneic Mesenchymal Stem Cells for Promoting Corneal Repair: Early Results. Investigative Ophthalmology & Visual Science, 2022. 63(7): p. 91 – A0189-91 – A0189.
5. Soleimani, M., et al., Applications of mesenchymal stem cells in ocular surface diseases: sources and routes of delivery. Expert Opin Biol Ther, 2023. 23(6): p. 509-525. 10.1080/14712598.2023.2175605
6. Jalilian, E., et al., Bone marrow mesenchymal stromal cells in a 3D system produce higher concentration of extracellular vesicles (EVs) with increased complexity and enhanced neuronal growth properties. Stem Cell Res Ther, 2022. 13(1): p. 425. 10.1186/s13287-022-03128-z
7. RoosterBio. Rapid Translation of a Cellular Therapeutic. RoosterBio webinar 2022; Available from: https://share.hsforms.com/1YmYCcqpoQLK_tn5AfWNzYQ3564o
8. Patel, A. S., et al., Encapsulation of angiogenic monocytes using bio-spraying technology. Integr Biol (Camb), 2012. 4(6): p. 628-32. 10.1039/c2ib20033c
9. Patel, A. S., et al., TIE2-expressing monocytes/macrophages regulate revascularization of the ischemic limb. EMBO Mol Med, 2013. 5(6): p. 858-69. 10.1002/emmm.201302752
10. Ludwinski, F. E., et al., Encapsulation of macrophages enhances their retention and angiogenic potential. NPJ Regen Med, 2019. 4: p. 6. 10.1038/s41536-019-0068-5
11. Patel, A. S., et al., HTATIP2 regulates arteriogenic activity in monocytes from patients with limb ischemia. JCI Insight, 2023. 8(24). 10.1172/jci.insight.131419
12. Patel, A. S., et al., A subpopulation of tissue remodeling monocytes stimulates revascularization of the ischemic limb. Sci Transl Med, 2024. 16(752): p. eadf0555. 10.1126/scitranslmed.adf0555
13. Allvaro, David, Patel, Ashish. Accelerating the Development of a Novel Cell Therapy for COVID-19–Associated Lung Fibrosis. pharma’s almanac 2021; Available from: https://www.pharmasalmanac.com/articles/accelerating-the-development-of-a-novel-cell-therapy-for-covid-19-associated-lung-fibrosis.
14. Williams, Kathy, Hansen, Caitlin. Quality Begins at Inception. RoosterBio Blog 2020; Available from: https://www.roosterbio.com/blog/quality-begins-at-inception/.
15. Bioh, G., et al., Prevalence of cardiac pathology and relation to mortality in a multiethnic population hospitalised with COVID-19. Open Heart, 2021. 8(2). 10.1136/openhrt-2021-001833