UFRJ Polilaminin Breakthrough: Anvisa Approves Human Trials for Spinal Cord Regeneration in Brazil

🧬 Decoding Polilaminin: A Brazilian Innovation in Regenerative Medicine

At the heart of this groundbreaking development is polilaminin, a sophisticated biomimetic polymer derived from laminin, a naturally occurring glycoprotein found in the extracellular matrix of human tissues, particularly the placenta. Laminin plays a crucial role in embryonic development by providing structural support and guiding neuronal growth, migration, and differentiation. In adults, however, its regenerative potential is limited after trauma like spinal cord injury (SCI).

Researchers at Brazil's Universidade Federal do Rio de Janeiro (UFRJ) discovered that by acidifying purified laminin extracted from human placenta, it self-assembles into polilaminin—a stable, three-dimensional filamentous network mimicking the embryonic neural scaffold. This polymer acts as a permissive substrate, countering the inhibitory glial scar that forms post-injury, which typically blocks axon regrowth. Step-by-step, polilaminin is prepared as a 100 μg/mL injectable solution, diluted in a specific buffer, and administered via direct intramedullary injection into the lesion site during surgery—rostrally and caudally at 1 mg/kg body weight.

This mechanism not only promotes axonal sprouting and elongation but also exhibits anti-inflammatory properties, reducing secondary damage from edema and immune responses. Unlike stem cell therapies or electrical stimulation, polilaminin leverages the body's own proteins, minimizing rejection risks.

From Lab Bench to Global Spotlight: UFRJ's 25-Year Journey

The story begins in the late 1990s at UFRJ's Instituto de Biofísica Carlos Chagas Filho (IBCCF), where biologist Tatiana Coelho-Sampaio, a professor and leading neuroscientist, accidentally observed laminin's polymerization during pH manipulation experiments. Over two decades, her team refined this into a viable therapy, securing funding from FAPERJ (Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro) and collaborating with Cristália Produtos Químicos Farmacêuticos Ltda. for scaling production.

Key milestones include initial rat models in 2010, chronic dog studies in 2025, and a pivotal pilot human trial concluding in 2022. Tatiana's persistence highlights Brazil's higher education strengths in translational research, where public universities like UFRJ drive biotech innovation despite funding challenges. Her work exemplifies how dedicated faculty can bridge basic science and clinical application, inspiring the next generation of researchers.

For aspiring academics, UFRJ's success underscores opportunities in research jobs within regenerative neuroscience, where interdisciplinary teams combine biology, chemistry, and neurosurgery.

Groundbreaking Preclinical Evidence from UFRJ Publications

UFRJ's research output forms a robust foundation, with peer-reviewed papers validating polilaminin's promise. The seminal 2010 study in The FASEB Journal tested polilaminin post-thoracic SCI in rats via compression or transection. Treated animals showed significant Basso-Beattie-Bresnahan (BBB) locomotor score improvements—from 4.2 to 8.8 points—indicating hindlimb stepping, alongside retrograde axon labeling confirming regrowth across lesions. Controls with non-polymerized laminin showed no benefits.

Building on this, a 2025 Frontiers in Veterinary Science paper detailed a longitudinal trial in six dogs with chronic thoracolumbar SCI. Polilaminin, combined with glial-derived neurotrophic factor (GDNF) or chondroitinase ABC, boosted Texas Spinal Cord Injury Scale (TSCIS) scores from 2.2 to 3.2 and open-field scores (OFS) from 1.5 to 3.1 (p<0.001), with no adverse events. These publications, led by Tatiana Coelho-Sampaio and collaborators like Karla Menezes, position UFRJ as a leader in SCI research.

• Rat model: Axon regeneration and motor recovery post-complete transection.
• Dog trial: Safe gait improvements in chronic cases, bridging veterinary and human applications.
• Anti-inflammatory effects: Reduced early locomotion deficits.

Such high-impact outputs enhance Brazil's research profile, attracting international collaborations.

Pilot Human Study: Early Signs of Functional Recovery

Transitioning to humans, UFRJ's REBEC-registered pilot (RBR-9dfvgpm), sponsored by Rio de Janeiro's Municipal Health Secretariat, enrolled eight acute complete SCI patients (AIS A, C4-T12 lesions <72 hours). Originally randomized, it shifted to open-label after one dramatic recovery prompted ethical review.

Injections during decompression surgery yielded remarkable results: 75% (6/8) converted to AIS C (incomplete, motor function preserved) or D within a year—far exceeding spontaneous rates (~15%). No neurological worsening, toxicity, or serious adverse events beyond expected surgical complications. Hematological parameters remained stable, affirming safety.

Patients reported gains from toe movement to trunk control and aided steps. This 2024 medRxiv preprint underscores polilaminin's potential, though larger trials are needed.

Anvisa Greenlights Phase 1: Safety Milestone Achieved

On January 5, 2026, Anvisa authorized Phase 1 via Resolution-RE N° 8, sponsored by Cristália. This prospective study targets five patients (18-72 years) with acute complete thoracic SCI (T2-T10, <72 hours, surgical candidates). Primary endpoint: Safety via adverse event monitoring, anti-drug antibodies, and pharmacokinetics.

Administered as a single intramedullary dose, it prioritizes good clinical practices with Anvisa's Innovation Committee oversight. Success paves the way for Phase 2 efficacy trials, potentially revolutionizing Brazil's SCI management.

Read Anvisa's official announcement.

Compassionate Use and Real-World Patient Outcomes

Before formal trials, Brazilian courts granted access to polilaminin for desperate patients. As of January 2026, six received it post-SCI; reports include a young Mato Grosso do Sul man regaining hand movement after tetraplegia and others achieving partial mobility.

Challenges arose—some deaths occurred, but the lab attributes them to underlying conditions, not the therapy. These cases highlight ethical tensions in experimental access, fueling calls for streamlined regulations.

Stories like Luiz Fernando Mozer's underscore hope: post-injection, he progressed from no movement to voluntary contractions.

SCI Burden in Brazil: Why This Matters

Brazil faces a heavy SCI toll: ~40% from traffic accidents, predominantly young males (mean age 38), with 59% paraplegia and 35% complete injuries. Mortality averages 11.6%, per systematic reviews. BRICS data (GBD 2021) project rising incidence, straining SUS (Unified Health System).

• Annual cases: Thousands, costing billions in rehab/lifelong care.
• Demographics: 69% male, urban trauma dominant.
• Global context: Brazil lags in therapies, making UFRJ's work vital.

Polilaminin could cut long-term disability, easing economic burdens.

Challenges, Risks, and Path Forward

Despite promise, hurdles remain: optimal dosing, combination therapies (e.g., with GDNF), long-term efficacy, and scalability. Immune responses or inconsistent polymerization pose risks, monitored rigorously.

Future: Phase 2/3 by 2027-2028, multicenter trials expanding to cervical injuries. UFRJ eyes partnerships for commercialization.

UFRJ's Role Elevates Brazilian Higher Education Research

This achievement spotlights UFRJ's prowess, ranking it among global leaders in neuroscience. It attracts grants, PhDs, and postdocs, fostering postdoc opportunities in regenerative medicine.

Brazilian universities produce high-impact SCI research, per Scopus metrics, but funding volatility demands advocacy. Explore Brazil university jobs or professor positions to contribute.

Global Implications and Career Horizons

Polilaminin's success could inspire SCI therapies worldwide, positioning Brazil in biotech exports. For professionals, it signals demand for experts in academic CVs tailored to research roles.

Check Rate My Professor for UFRJ insights or higher ed jobs in neuroscience. As trials advance, watch for openings in clinical research.

Optimism abounds: Tatiana Coelho-Sampaio vows bolder publishing, accelerating translation. Brazil's academia stands ready to heal.