Miracell Demonstrates Cognition Impairment and Brain Function Improvement in Severe Alzheimer's Patients Using 'SMART M-CELL'-Based CD34+ Cell-Rich Autologous Blood Concentrate Therapy

• Study published in SCIE-indexed international journal Molecular Neurobiology
• Three intravenous infusions at four-week intervals showed benefits in cognition, brain metabolism, and structural preservation

SEOUL, South Korea, April 24, 2026 /PRNewswire/ -- Miracell, a stem cell-focused biotechnology company, announced that clinical results have demonstrated significant cognitive improvement and preservation of brain function in patients with moderate to severe Alzheimer's disease using CD34+ cell-rich autologous blood concentrate prepared through its FDA 510(k)-cleared cell extraction platform, SMART M-CELL.

The study was led by the research team of Professor Emeritus Gyung Whan Kim at Yonsei University Severance Hospital, and the findings were published in the Q1-ranked SCIE-indexed international neuroscience journal Molecular Neurobiology.

SMART M-CELL: Core Technology Behind the Clinical Outcomes

According to the paper, Therapeutic Efficacy of Autologous Blood-Derived Stem Cells with Growth Factors in Moderate to Severe Alzheimer's Disease: A Clinical Trial, researchers used the SMART M-CELL system to precisely isolate and concentrate CD34+ cell-rich autologous blood concentrate and growth factors from patients' own blood for clinical treatment.

At the beginning of the study, 220–260 mL of peripheral blood was collected from each participant and processed using SMART M-CELL2 to separate blood components and obtain peripheral blood mononuclear cells (PBMCs), including CD34+ cells and mesenchymal stem cell populations. Flow cytometry analysis showed that 0.5% to 1.5% of isolated mononuclear cells met adult stem cell criteria (ABSC: CD34⁺CD45dim, CD73⁺, CD105⁺, viability above 95%).

The CD34+ cell-rich autologous blood concentrate was administered intravenously in a pure state within three hours of isolation, without ex vivo expansion. Growth factors were delivered after cell infusion. Dosages were individually adjusted based on body weight and tolerability using established mesenchymal and hematopoietic stem cell clinical protocols.

Patients received a total of three intravenous treatments at four-week intervals, with safety, efficacy, and biological responses assessed at one, three, and six months after the final treatment.

Significant Improvements in Cognition, and Brain Preservation

Cognitive assessments were conducted at baseline and again at three and six months using MMSE, CDR-SOB, and ADAS-Cog scales. All evaluations were performed by blinded clinical specialists. Results in the SMART M-CELL treatment group showed meaningful benefits, including:

• Significant improvement in memory and cognition markers such as MMSE, CDR, and ADAS-Cog
• Reduction of amyloid burden, a hallmark pathological protein in Alzheimer's disease
• Increased brain glucose metabolism observed through FDG-PET imaging
• Preservation of brain structure, including reduced hippocampal atrophy on MRI
• Favorable safety profile with no serious adverse events

By contrast, the control group receiving only conventional treatment showed no notable improvements in cognitive function or brain imaging biomarkers.

A New Therapeutic Option for Slowing Alzheimer's Progression

Blood analyses also showed reductions in pro-inflammatory markers, while protective signaling pathways associated with neuronal survival and recovery were activated. These findings suggest that purified and concentrated CD34+ cell-rich autologous blood concentrate may help not only relieve symptoms but also influence disease progression itself.

The Severance Hospital neurology research team stated that the study demonstrated real-world clinical evidence of improved cognition, reduced amyloid plaque burden, and enhanced neuroimaging indicators through administration of CD34+ cell-rich autologous blood concentrate and growth factors. Because the therapy uses the patient's own blood, it may carry lower risk of immune rejection and offer a practical treatment strategy for elderly patients.

The researchers further noted that by simultaneously targeting multiple mechanisms, including neuroprotection and enhanced neural plasticity, CD34+ cell-rich autologous blood concentrate therapy may open new possibilities for treating Alzheimer's disease and other neurodegenerative disorders.

Internationally Validated Clinical Treatment Platform

Hyun-soon Shin, Chairman of Miracell, said Alzheimer's disease places a tremendous social and economic burden on both patients and caregivers, while treatment options have remained limited. She added that SMART M-CELL-based cell therapy has clinically demonstrated symptom improvement through neuroprotection, regenerative support, and inflammation control, presenting a new therapeutic alternative for patients with moderate to severe Alzheimer's disease

She further stated that publication in an SCIE-indexed journal validates SMART M-CELL as an internationally recognized clinical treatment platform capable of reliably securing high-concentration, high-viability CD34+ cell-rich autologous blood concentrate, and that the company plans to expand its applications into other difficult-to-treat conditions, including degenerative brain diseases.

Miracell Targets U.S. Market Following FDA 510(k) Clearance

The United States remains the world's largest healthcare market and one of the fastest-growing markets for regenerative medicine. Against this backdrop, Miracell is positioning SMART M-CELL not merely as a device, but as an integrated regenerative medicine platform spanning CD34+ cell-rich autologous blood concentrate preparation, bone marrow cell extraction, and clinical application.

The company stated that following its recent U.S. Food and Drug Administration 510(k) clearance, it plans to expand collaboration with hospitals and clinics in the United States while accelerating global partnership development.

The FDA 510(k) clearance was obtained for an integrated system combining the extraction device with blood and bone marrow kits. SMART M-CELL is designed to isolate and concentrate CD34+ cell-rich blood fractions and growth factors derived from patients' own blood and bone marrow.

Its streamlined workflow—from collection to separation to application—was engineered to standardize the treatment process under a consistent protocol, minimizing operator variability and ensuring the reproducibility required in clinical settings.

Based on this technological foundation, SMART M-CELL is being utilized as a scalable regenerative medicine platform across multiple specialties, including neurology, orthopedics, pain management, dermatology, and aesthetic medicine.

For more information, visit: https://miracell.co.kr/en/  

SOURCE Miracell