4th State MedicalRegenerative · Technology
Research Library

Science, organized and continuously updated.

A central resource for scientific publications, studies, white papers, presentations, posters, videos, patents, and clinical collaborations.

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Featured research
01

Selected work shaping the platform.

Curated publications and technical papers that anchor current programs across regenerative biology, device engineering, and evidence generation.

Peer-Reviewed Publications2024-01-03

Improvements in Diabetic Neuropathy with Topical Human Mesenchymal Stem Cell Conditioned Media

Pilot study of a topical mesenchymal stem cell media–conditioned cream (Neurocream) applied twice daily to the soles of the feet after brief micro-needling in type-2 diabetic and non-diabetic patients with progressive neuropathy. T2D participants reported approximately a 50% average reduction across foot pain, tingling, and swelling at 30 days; non-T2D participants reported a 57% reduction in swelling and 40% reduction in foot pain. All participants reported improved sleep.

Jonathan R.T. Lakey, PhD, David Whaley, Tony Alfiere, Michael Alexander, Charles Drummond III · Am J Biomed Sci & Res. 2024;21(1)
#MSC#Conditioned Media#Neuropathy#Diabetes
Peer-Reviewed Publications2024-10-23

Reduction in Age-Related Skin Damage Using Products Incorporating Novel Topical Human Mesenchymal Stem Cell Conditioned Media

Pilot clinical trial (n=12) evaluating a topical stem cell–conditioned skin cream applied over eight weeks to address age-related skin concerns including tone, texture, brightness, and fine lines. Discussion covers the biology of skin senescence, paracrine signaling by MSCs, and the growth-factor and cytokine cargo underlying observed improvements in skin aesthetics.

Jonathan R.T. Lakey, PhD, David Whaley, Tony Alfiere, Ian Jenkins, Michael Alexander · Am J Biomed Sci & Res. 2024;24(3)
#MSC#Skin Aging#Cosmeceutical#Microneedling
Peer-Reviewed Publications2023-10-28

Exosomes; a Potential Source of Biomarkers, Therapy, and Cure for Type-1 Diabetes

Comprehensive review of exosome biology across biomarker discovery, therapeutic delivery, and disease-modifying strategies in type-1 diabetes. Covers exosome biogenesis, cargo-mediated cellular crosstalk, autoimmune pathways in β-cell dysfunction, and the translational path toward exosome-based diagnostics and therapies, with implications for type-2 diabetes as well.

Jonathan R.T. Lakey, PhD, Yanmin Wang, Michael Alexander, Mike K.S. Chan, Michelle B.F. Wong, Krista Casazza, Ian Jenkins · Int. J. Mol. Sci. 2023;24(21):15713
#Exosomes#Extracellular Vesicles#T1D#Biomarkers#miRNA
White Papers2025-06-01

Design Considerations for Connected Regenerative Delivery Devices

Architectural considerations for building traceable, evidence-ready device systems intended for regenerative delivery, including consumable authentication, telemetry, and audit paths.

4th State Medical Engineering Team · 4th State Medical — White Paper
#Device#Connectivity#Traceability
Recent additions
02

Most recently added to the library.

2025-06-01
White Papers
Design Considerations for Connected Regenerative Delivery Devices
4th State Medical Engineering Team · 4th State Medical — White Paper

Architectural considerations for building traceable, evidence-ready device systems intended for regenerative delivery, including consumable authentication, telemetry, and audit paths.

#Device#Connectivity#Traceability
View →
2025-05-30
Regulatory & Technical
Regulatory Considerations for Connected Regenerative Medical Devices
4th State Medical Regulatory Affairs · Technical Note

Regulatory-classification considerations for connected regenerative medical device platforms, mapping features to expected review pathways.

#Regulatory#Connected#Classification
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2025-03-15
Clinical Research
Investigator-Initiated Study Protocol Template — Regenerative Applications
4th State Medical Clinical Affairs · Clinical Program Document

A standardized protocol template supporting investigator-initiated studies aligned with the 4th State Medical evidence framework.

#Protocol#IIS#Collaboration
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2025-02-01
Conference Presentations
Presentation: The Fourth State — An Integrated Regenerative Platform
4th State Medical Leadership · Industry Conference (placeholder)

Conference presentation outlining the integrated regenerative platform thesis and near-term milestones.

#Vision#Platform
View →
Full library
04

Search and filter every entry.

12 results
2025-06-01
White Papers
Design Considerations for Connected Regenerative Delivery Devices
4th State Medical Engineering Team · 4th State Medical — White Paper

Architectural considerations for building traceable, evidence-ready device systems intended for regenerative delivery, including consumable authentication, telemetry, and audit paths.

#Device#Connectivity#Traceability
View →
2025-05-30
Regulatory & Technical
Regulatory Considerations for Connected Regenerative Medical Devices
4th State Medical Regulatory Affairs · Technical Note

Regulatory-classification considerations for connected regenerative medical device platforms, mapping features to expected review pathways.

#Regulatory#Connected#Classification
View →
2025-03-15
Clinical Research
Investigator-Initiated Study Protocol Template — Regenerative Applications
4th State Medical Clinical Affairs · Clinical Program Document

A standardized protocol template supporting investigator-initiated studies aligned with the 4th State Medical evidence framework.

#Protocol#IIS#Collaboration
View →
2025-02-01
Conference Presentations
Presentation: The Fourth State — An Integrated Regenerative Platform
4th State Medical Leadership · Industry Conference (placeholder)

Conference presentation outlining the integrated regenerative platform thesis and near-term milestones.

#Vision#Platform
View →
2025-01-22
Patents & IP
Patent Application: Connected Consumable Authentication Architecture for Regenerative Delivery
4th State Medical · USPTO (application, placeholder)

System and methods for authenticating single-use consumables in a connected regenerative delivery platform, including cryptographic pairing and use-count enforcement.

#IP#Consumables#Authentication
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2025-01-05
Company Publications
Introducing 4th State Medical
4th State Medical · Company Announcement

An introduction to 4th State Medical and its integrated regenerative technology platform.

#Announcement#Company
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2024-11-07
Peer-Reviewed Publications
Clinical Evaluation of the Efficacy of a Topical Acne Product in Improving Skin Conditions
Jonathan R.T. Lakey, PhD, Krista Casazza, Tony Alfiere, Ian Jenkins, Michael Alexander · Am J Biomed Sci & Res. 2024;24(4)

Single-center 30-day clinical study (n=15, ages 18–43) of a topical acne product combining stem cell–conditioned media with salicylic acid. Analysis showed a statistically significant improvement in overall acne lesion appearance from baseline at day 30 (p=0.004) and strong participant-reported improvements in skin texture, with a favorable safety profile.

#MSC#Acne#Salicylic Acid#Clinical
View →
2024-10-23
Peer-Reviewed Publications
Reduction in Age-Related Skin Damage Using Products Incorporating Novel Topical Human Mesenchymal Stem Cell Conditioned Media
Jonathan R.T. Lakey, PhD, David Whaley, Tony Alfiere, Ian Jenkins, Michael Alexander · Am J Biomed Sci & Res. 2024;24(3)

Pilot clinical trial (n=12) evaluating a topical stem cell–conditioned skin cream applied over eight weeks to address age-related skin concerns including tone, texture, brightness, and fine lines. Discussion covers the biology of skin senescence, paracrine signaling by MSCs, and the growth-factor and cytokine cargo underlying observed improvements in skin aesthetics.

#MSC#Skin Aging#Cosmeceutical#Microneedling
View →
2024-09-20
Preclinical Research
Preclinical Evaluation Methodology for Regenerative Delivery Systems
Placeholder Preclinical Team · Preclinical Report (placeholder)

A methodology summary for evaluating delivery systems across relevant preclinical models, including endpoints, controls, and reporting standards.

#Preclinical#Methodology
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2024-04-16
Peer-Reviewed Publications
Novel Methods to Preserve Mesenchymal Stem Cells at Low Temperatures
Jonathan R.T. Lakey, PhD, Wenyi Guo, Carolina Bluguerman, Tori Tucker, Michael Alexander, Adrian Mutto · Am J Biomed Sci & Res. 2024;22(1)

Validation of a combinational cryoprotectant strategy using lower-than-conventional concentrations of two permeating agents (DMSO and ethylene glycol) with a stepwise sucrose dilution during recovery. The optimized protocol yielded significantly higher post-thaw MSC viability (~80%) versus conventional DMSO-only approaches, supporting more effective banking of stem cells for downstream therapeutic use.

#Cryopreservation#MSC#Manufacturing
View →
2024-01-03
Peer-Reviewed Publications
Improvements in Diabetic Neuropathy with Topical Human Mesenchymal Stem Cell Conditioned Media
Jonathan R.T. Lakey, PhD, David Whaley, Tony Alfiere, Michael Alexander, Charles Drummond III · Am J Biomed Sci & Res. 2024;21(1)

Pilot study of a topical mesenchymal stem cell media–conditioned cream (Neurocream) applied twice daily to the soles of the feet after brief micro-needling in type-2 diabetic and non-diabetic patients with progressive neuropathy. T2D participants reported approximately a 50% average reduction across foot pain, tingling, and swelling at 30 days; non-T2D participants reported a 57% reduction in swelling and 40% reduction in foot pain. All participants reported improved sleep.

#MSC#Conditioned Media#Neuropathy#Diabetes
View →
2023-10-28
Peer-Reviewed Publications
Exosomes; a Potential Source of Biomarkers, Therapy, and Cure for Type-1 Diabetes
Jonathan R.T. Lakey, PhD, Yanmin Wang, Michael Alexander, Mike K.S. Chan, Michelle B.F. Wong, Krista Casazza, Ian Jenkins · Int. J. Mol. Sci. 2023;24(21):15713

Comprehensive review of exosome biology across biomarker discovery, therapeutic delivery, and disease-modifying strategies in type-1 diabetes. Covers exosome biogenesis, cargo-mediated cellular crosstalk, autoimmune pathways in β-cell dysfunction, and the translational path toward exosome-based diagnostics and therapies, with implications for type-2 diabetes as well.

#Exosomes#Extracellular Vesicles#T1D#Biomarkers#miRNA
View →
NoticePublication of a study or reference does not imply that the material described represents any specific commercial product of 4th State Medical, nor that any product has been evaluated for the indications discussed in referenced literature. PDFs and external links marked with placeholders will be replaced with vetted assets prior to publication.