Polylaminin and the Challenge of Elevating Brazilian Biomedical Innovation Beyond the Promise
- Alma Mater Cosméticos
- Sep 16
- 7 min read
Polylaminin: a provocative discovery, but requires caution
Recently, a piece of scientific news emerged with great repercussion: scientists from the Federal University of Rio de Janeiro (UFRJ) are working with a molecule called polylaminin, derived from the laminin protein extracted from the human placenta, which has demonstrated, in initial studies, the ability to restore movement in patients with severe spinal cord injury (tetraplegia/paraplegia) and in animal models.
It's an admirable feat, symbolizing the immense potential of Brazilian clinical research. But beyond the excitement, this case invites us to carefully examine the data, the methodological limitations, and the remaining steps—especially in regulation, support structure, funding, and scalability.
The polylaminin case clearly demonstrates what is possible when three fundamental elements align in Brazil: cutting-edge scientific capacity , a domestic industry with an appetite for innovation , and a minimally functional regulatory system to enable clinical research into complex therapies. But this alignment is still the exception, not the rule.
Scientific context: what is known so far
UFRJ is one of the largest and most productive universities in Latin America. Its installed capacity for research in bioengineering, neuroscience, and bioprocesses is internationally recognized. However, initiatives like the polylaminin project are rare, not for lack of talent, but for the absence of continuous translational funding mechanisms . Even today, many discoveries die in the "valley of death" between the bench and the shelf.
Preclinical studies and animal models
Recent publications ( Frontiers in Veterinary Sciences , among others) report the use of polylaminin in paraplegic dogs: six animals with paraplegia, unsuccessful after conventional surgery and physical therapy, received the substance applied directly to the spinal cord. In four cases, there was recovery of gait and independent steps after months of follow-up.
No serious side effects were reported in animals, and direct applicability to the spinal cord with a surgical protocol and intensive physiotherapy appears feasible in these preclinical models.
First experimental human data
There are reports of Brazilian patients who participated in early studies with polylaminin, under academic protocols. The number of volunteers is quite small (less than 10 in many versions of the media coverage), and the data are heterogeneous: some managed to recover minimal movements (such as moving fingers or the trunk), others achieved more extensive recoveries, but still below a robust standard of clinical control.
In one of the best-documented cases, patient Bruno Drummond reports gradual and significant recovery since receiving treatment, although media reports acknowledge that he had immediate physical therapy, clinical support conditions, and that the treatment was applied in the acute phase of the injury, which favors better results.
Regulation, safety and current phase
Anvisa has not yet approved widespread clinical use or registration of polylaminin as a drug. Available information indicates that it is in the experimental/regulatory clinical trial phase, with safety and efficacy analysis pending.
Research funding comes from public institutions such as FAPERJ , and a national laboratory ( Cristália ) participates in experimental manufacturing. This is important because it demonstrates local production capacity and institutional interest.
Regulatory landscape and ecosystem of advanced therapies in Brazil
Historically conservative, ANVISA has signaled progress in incorporating regulatory frameworks for advanced therapies, such as gene, cell, and tissue therapy products. The launch of Good Practice Guides for Advanced Therapy Products and the creation of channels for dialogue with researchers and companies are important steps.
To contextualize what polylaminin represents, it is important to map where we are with advanced therapies in Brazil:
Regulation of advanced therapies / Advanced Therapy Products (PTA) : standards such as RDC 214/2018, RDC 260/2018 defined requirements for clinical research with investigational advanced therapy products; RDC 505/2021 regulates registrations of these products with post-registration monitoring conditions.
Law No. 14,874/2024 : Recently approved, this law regulates clinical research involving human subjects, bringing Brazil more into line with international standards. According to the Brazilian Pharmaceutical Industry Association (Abifina), this facilitates regulatory processes for innovative products.
Anvisa monitoring reports for advanced therapy products: A commitment to transparency has been in place, analyzing approved products since 2020 and monitoring efficacy and safety post-registration. These reports reinforce the need for long-term evidence to ensure a favorable benefit-risk balance.
Authorized clinical trials : As part of this regulatory ecosystem, dozens of clinical trials involving advanced therapy products have been authorized since 2018. This demonstrates a regulatory environment in place that allows for innovation, albeit at a slow pace.
Robust challenges ahead
With all these advances, challenges remain many and crucial for innovations like polylaminin to reach patients safely and at scale:
Rigorous scientific validation
It is necessary to move towards controlled, randomized, multicenter trials with a larger number of volunteers to generate reliable statistics.
Control important variables such as timing of post-injury application (acute vs chronic phase), optimal dose, surgical and rehabilitation support (physiotherapy, nutrition, intensive care).
Long-term safety and adverse effects
Although no serious adverse effects directly related to polylaminin have been reported in initial studies to date, the sample size is small and the follow-up time is still limited.
Continuous monitoring and regulatory engagement terms are essential to capture late effects or in diverse populations.
Scalability and production
Producing a high-purity, consistent, biologically active compound on a scale compatible with larger clinical trials requires laboratories with capacity, standardized processes, quality control, and certifications.
The partnership with Cristália is promising, but production costs, industrial viability, and supply chain challenges (placentas as raw material, processing, ensuring biological safety, etc.) are still unknown.
Regulation, technical standards and recognition
Brazilian legislation on advanced therapies has been modernized, but some specific standards are still being proposed or under consultation, such as technical standards for clinical trials of advanced therapies that consider particularities such as human tissues, extracellular matrix, biomaterials, etc.
Pricing rules and incorporation into the SUS for high-cost therapies remain a challenge; the Drug Market Regulation Commission (CMED) is still working on models that consider cost, efficacy, durability, real impact, and reimbursement capacity. ( ABIFINA )
Financing and institutional support structure
Long-term research funding: grants, public funds such as FAPERJ, FINEP, and statistical policies that prioritize deeptechs .
Public-private support and national industries with an appetite for technological risk are essential.
Research infrastructure, GMP laboratories, collaboration networks, training of specialized professionals (surgery, neuroscience, biomedical engineering).
Why polylaminin is symbolic – and what possibilities it reveals
Cristália has a history of developing proprietary assets, such as anesthetics and biopharmaceuticals. It's an exception in a market where most Brazilian laboratories still focus their efforts on generics, similar products, and multinational licenses. Radical development initiatives involve high risk, long cycle times, and intensive investment—a profile that's poorly compatible with the traditional financial logic of the Brazilian private sector.
But that's changing. Cases like Biomm, Blau, Biolab, and Cristália itself show that there's a new generation of Brazilian pharmaceutical companies seeking to go beyond the industry's bread and butter. The challenge now is to expand these examples, connect with deeptech startups , and build a support infrastructure that makes these risks more palatable.
Polylaminin is not just another experiment; it embodies a model that combines:
Long-term vision in academic science (UFRJ has been researching laminin for decades);
Local production capacity (with national laboratory involved);
Direct surgical application, with a clear clinical protocol, immediate support physiotherapy, care during application time;
Institutional support in science and regulation that, if strengthened, could serve as a model for other advanced therapies.
This type of effort breaks with narratives of “external technological dependence” and shows that we are indeed capable of discovering, developing, and testing cutting-edge regenerative therapies—even with the inevitable risks and many unknowns.
Projections, market data and international comparisons
Brazil is among the Latin American countries with the most advanced regulatory environment for advanced therapies (PTAs), thanks to the 2018/2021 RDCs, Law 14.874/2024 and the work of networks of technical experts such as Reneta/ANVISA.
According to data from ABIFINA , the number of authorized clinical trials with PTAs in Brazil has been growing: more than 60 studies since 2018 involving biological products, cells, tissues or tissue engineering.
Comparatively, international markets (US, EU, Canada) are investing billions of dollars in regenerative therapies and deeptech healthcare; startup valuations, industrial partnerships, venture capital, and M&A in this sector have intensified. This global scenario also raises expectations for countries that maintain high-quality science.
Personal reflections: from the experience with COINFAR and undertaking innovation in Brazil
My recent and long-standing experience shows that many of the elements necessary for disruptive innovation already exist in Brazil, but the “systemic gap ” sometimes demands difficult strategic decisions:
At COINFAR , we saw that industry-academia cooperation can generate solutions, but also that without stable policies and a state vision, these efforts lose momentum.
Undertaking deep science-based ventures (deeptechs) means accepting longer cycles, regulatory risk, the need for early dialogue with regulatory bodies, patient capital investments, and a clear intellectual property strategy.
Polylaminin will be at the center of this debate: whether it is a success story or remains a promise depends much more on the ecosystem than on the molecule itself.
Path to effective translation
The discovery of polylaminin is one of the most inspiring moments in recent Brazilian biotechnology—but its promise is still far from becoming a widespread clinical reality. To achieve this, it will be necessary:
Carry out new robust clinical phases, with different centers, larger samples, and more rigorous methodological designs;
Long-term security assurance and constant regulatory surveillance;
Industrial scale production with controlled quality;
Establish sustainable financing models for deeptechs in healthcare;
Adjust regulatory and public policy incorporation standards for advanced therapies that tend to be expensive but have significant potential social benefits.
If all of this aligns, we could have in Brazil not only a promising molecule, but a robust innovation trajectory that helps patients, strengthens national science, and puts the country on the world map of regenerative therapies.
The polylaminin case offers us more than hope; it forces us to rethink the environment we want to cultivate for Brazilian science to flourish. We need to expand the instruments for promoting translational research, strengthen bridges between universities and companies with real production capacity, and ensure that regulation keeps pace with, but doesn't stifle, the advancement of biomedical technologies. Projects like this require time, perseverance, and an ecosystem that knows where its rare gems lie.
At IBIS, we remain alert to the signs of the present that portend the future and we are committed to strengthening this fertile ground where innovation and social impact can truly coexist. We are committed to articulating this ecosystem: supporting dedicated scientists, connecting them with national industries, fostering effective public policies, and advocating for regulation that enables innovation without sacrificing safety.
If you're working in biomedical research, healthcare entrepreneurship, or policymaking, contact us and let's discuss how your journey could be just the beginning of something much bigger.
by Marcio de Paula
Brazilian Health Innovation Institute - IBIS