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## RegenBrief **Operator**: DYPHI Inc. **Purpose**: Clinical archive and research notes on functional longevity, frailty, cognition, and regenerative medicine — curated in Korean. **Update cadence**: Trial statuses sync daily with ClinicalTrials.gov API v2. **Disclaimer**: Academic reference only. Not medical advice. --- ## Site Structure | Section | URL | Description | |---|---|---| | Home | / | Overview and recent entries | | Clinical Archive | /clinical-archive/ | All curated clinical trials | | Research Notes | /research-notes/ | DYPHI internal research | | Policy Analysis | /policy/ | Korean regulatory analysis | | By Indication | /by-indication/ | Filter by disease area | | By Cell Source | /by-cell-source/ | Filter by cell/exosome type | | By Phase | /by-phase/ | Filter by trial phase | | By Region | /by-region/ | Filter by sponsor country | --- ## Clinical Archive — All Entries Each entry: NCT trial · cell source · indication · phase · status · key finding. ### UC-MSC Injection — 제대 유래 MSC, 간질성 폐질환 Phase 1 **URL**: /clinical-archive/2026-ucmsc-ild-phase1/ **NCT ID**: NCT06534528 **Sponsor**: Shanghai Life Science & Technology (China) **Cell Source**: 제대 중간엽줄기세포 (UC-MSC) · allogeneic **Indication**: interstitial-lung-disease **Phase**: PHASE 1 **Status**: NOT-YET-RECRUITING **Delivery**: 주사 (systemic administration) **Enrollment**: 24 **Summary**: — **Tags**: interstitial-lung-disease, uc-msc, phase-1, pulmonary ### SECRET-OA — UC-MSC secretome, 골관절염 통증·기능 개선 Phase 2/3 **URL**: /clinical-archive/2026-secret-oa-ucmsc-secretome-phase23/ **NCT ID**: NCT07337863 **Sponsor**: Universitas Sriwijaya (Indonesia) **Cell Source**: 제대 중간엽줄기세포 (UC-MSC) · allogeneic **Indication**: 무릎 골관절염 (Knee Osteoarthritis) **Phase**: PHASE 2 3 **Status**: NOT-YET-RECRUITING **Delivery**: 관절강 내 주사 (intra-articular injection) **Enrollment**: 50 **Summary**: — **Tags**: osteoarthritis, uc-msc, secretome, intra-articular, phase-2-3 ### Rincell-1 — 청각 신경전구세포, 인공와우 병합 first-in-human 임상 **URL**: /clinical-archive/2026-rincell1-otic-progenitor-hearing-phase12/ **NCT ID**: NCT07032038 **Sponsor**: Rinri Therapeutics (UK) **Cell Source**: otic-neural-progenitors · allogeneic **Indication**: sensorineural-hearing-loss **Phase**: PHASE 1 2 **Status**: NOT-YET-RECRUITING **Delivery**: 인공와우 수술 중 세포 주입 **Enrollment**: 20 **Summary**: — **Tags**: hearing-loss, otic-progenitors, cochlear-implant, first-in-human, phase-1-2 ### RepCOPDiPS — iPS 세포 기반 기관지 상피 복구 모델 **URL**: /clinical-archive/2026-repcopdips-ips-copd-exvivo/ **NCT ID**: NCT06755008 **Sponsor**: University Hospital, Montpellier (France) **Cell Source**: ips · autologous **Indication**: copd **Phase**: NA **Status**: RECRUITING **Delivery**: 환자 투여 없음 (ex vivo graft model) **Enrollment**: 50 **Summary**: — **Tags**: COPD, ips, ex-vivo, bronchial-epithelium, translational ### NSC-EVs — 신경줄기세포 유래 엑소좀, 조기 발병 알츠하이머병 Phase 1 **URL**: /clinical-archive/2026-nsc-evs-alzheimers-phase1/ **NCT ID**: NCT07554872 **Sponsor**: Shanghai Mental Health Center (China) **Cell Source**: 신경줄기세포 (NSC) · allogeneic **Indication**: 알츠하이머병 (Alzheimer's Disease) **Phase**: PHASE 1 **Status**: NOT-YET-RECRUITING **Delivery**: 비강 투여 (intranasal) **Enrollment**: 9 **Summary**: — **Tags**: alzheimers, nsc, exosomes, intranasal, phase-1, early-onset ### NouvNeu001 — 도파민성 전구세포, 파킨슨병 신경재생 Phase 1/2 **URL**: /clinical-archive/2026-nouvneu001-dopaminergic-parkinson-phase12/ **NCT ID**: NCT07102342 **Sponsor**: iRegene Therapeutics Co., Ltd. (China) **Cell Source**: dopaminergic-progenitor · allogeneic **Indication**: 파킨슨병 (Parkinson's Disease) **Phase**: PHASE 1 2 **Status**: RECRUITING **Delivery**: 세포 주입 (intracerebral transplantation) **Enrollment**: 5 **Summary**: — **Tags**: parkinsons-disease, dopaminergic-progenitor, intracerebral, phase-1-2 ### MSC Gel — 중간엽줄기세포 겔, 화상 창상 치료 임상 **URL**: /clinical-archive/2026-msc-gel-burn-wound/ **NCT ID**: NCT07580755 **Sponsor**: The First Affiliated Hospital of Xinxiang Medical College (China) **Cell Source**: msc · allogeneic **Indication**: burn-wound **Phase**: NA **Status**: RECRUITING **Delivery**: 국소 적용 (stem cell gel) **Enrollment**: 90 **Summary**: — **Tags**: burn-wound, msc, topical, gel, wound-healing ### hUCMSC-EVs — 제대 MSC 유래 세포외소포, 간질성 폐질환 Phase 1 **URL**: /clinical-archive/2026-hucmsc-evs-ild-phase1/ **NCT ID**: NCT07570836 **Sponsor**: Shanghai Zhongshan Hospital (China) **Cell Source**: 제대 중간엽줄기세포 (UC-MSC) · allogeneic **Indication**: interstitial-lung-disease **Phase**: PHASE 1 **Status**: NOT-YET-RECRUITING **Delivery**: 흡입 투여 (nebulized inhalation) **Enrollment**: 24 **Summary**: — **Tags**: interstitial-lung-disease, uc-msc, extracellular-vesicles, inhalation, phase-1 ### HiCM-188 — iPSC 유래 심근세포, 진행성 심부전 Phase 3 **URL**: /clinical-archive/2026-hicm188-ipsc-heart-failure-phase3/ **NCT ID**: NCT07496372 **Sponsor**: HELP Therapeutics Co., Ltd. (China) **Cell Source**: 유도만능줄기세포 (iPSC) · allogeneic **Indication**: 심부전 (Heart Failure) **Phase**: PHASE 3 **Status**: RECRUITING **Delivery**: 심근 주사 (CABG 병합) **Enrollment**: 80 **Summary**: — **Tags**: heart-failure, ipsc, cardiomyocytes, phase-3, CABG ### EXO-DEX-SNHL — Dexamethasone-loaded Exosomes, 급성 감각신경성 난청 고실 내 약물전달 임상 **URL**: /clinical-archive/2026-exo-dex-snhl-exosome-hearing/ **NCT ID**: NCT07568184 **Sponsor**: Kafrelsheikh University (Egypt) **Cell Source**: 제대 중간엽줄기세포 (UC-MSC) · allogeneic **Indication**: sensorineural-hearing-loss **Phase**: NA **Status**: RECRUITING **Delivery**: 고실 내 투여 (intratympanic delivery) **Enrollment**: 30 **Summary**: — **Tags**: hearing-loss, exosome, drug-delivery, dexamethasone, intratympanic ### ExoFlo — 골수 MSC 엑소좀, 염증·호흡기 적응증 Phase 2/3 **URL**: /clinical-archive/2025-exoflo-ards-phase23/ **NCT ID**: NCT05354141 **Sponsor**: Direct Biologics (USA) **Cell Source**: MSC 유래 엑소좀 (MSC-Exo) · allogeneic **Indication**: 코로나19 ARDS (COVID-19 ARDS) **Phase**: PHASE 2 3 **Status**: ACTIVE **Delivery**: 정맥주입 (IV) **Enrollment**: 102 **Summary**: 엑소좀 기반 치료제 중 가장 진전된 후기 임상. 중등도~중증 COVID-19 ARDS 대상. **Tags**: ARDS, exosome, ExoFlo, late-stage, FDA-EUA-applied ### WJ-MSC 만성 완전 척수손상 Phase I — Kaplan 외 **URL**: /clinical-archive/2025-wj-msc-spinal-cord-injury/ **NCT ID**: NCT05152290 **Sponsor**: Stem Cell of America (USA) **Cell Source**: 와튼젤리 중간엽줄기세포 (WJ-MSC) · allogeneic **Indication**: 척수손상 (Spinal Cord Injury) **Phase**: PHASE 1 **Status**: ACTIVE **Delivery**: 척수강 내 (intrathecal) **Enrollment**: 10 **Summary**: 만성 완전 척수손상 환자 대상 WJ-MSC 척수강 내 투여 안전성·운동기능 평가. **Tags**: spinal-cord-injury, wj-msc, intrathecal, chronic ### Laromestrocel — 경증 알츠하이머병 동종 골수 MSC Phase 2a **URL**: /clinical-archive/2025-laromestrocel-ad-phase2a/ **NCT ID**: NCT05233774 **Sponsor**: Longeveron (USA) **Cell Source**: 골수 중간엽줄기세포 (BM-MSC) · allogeneic **Indication**: 알츠하이머병 (Alzheimer's Disease) **Phase**: PHASE 2A **Status**: COMPLETED **Delivery**: 정맥주입 (IV) **Enrollment**: 49 **Summary**: ARIA(아밀로이드 관련 영상 이상) 없음. 9개월 시점 인지·뇌위축 완화 신호 관찰. **Publication**: Nature Medicine 2025 · DOI: https://doi.org/10.1038/s41591-025-03559-0 **Tags**: alzheimers, bm-msc, allogeneic, ARIA-free, longeveron ### 와튼젤리 MSC 무릎 골관절염 — 폴란드 다기관 Phase I/II **URL**: /clinical-archive/2024-wj-msc-knee-osteoarthritis-warsaw/ **NCT ID**: NCT03866330 **Sponsor**: Medical University of Warsaw (Poland) **Cell Source**: 와튼젤리 중간엽줄기세포 (WJ-MSC) · allogeneic **Indication**: 무릎 골관절염 (Knee Osteoarthritis) **Phase**: PHASE 1 2 **Status**: ACTIVE **Delivery**: 관절강 내 주사 (intra-articular) **Enrollment**: 30 **Summary**: 초음파 유도 하 무릎·고관절·견관절 OA에 WJ-MSC 1,000만 세포 단회 주사. **Tags**: osteoarthritis, wj-msc, intra-articular, poland ### ahaMSCs-Exos — 알츠하이머 비강 투여 엑소좀 Phase I/II **URL**: /clinical-archive/2023-ahamscs-exos-ad-intranasal/ **NCT ID**: NCT04388982 **Sponsor**: Ruijin Hospital (China) **Cell Source**: 지방 MSC 유래 엑소좀 (AD-MSC-Exo) · allogeneic **Indication**: 알츠하이머병 (Alzheimer's Disease) **Phase**: PHASE 1 2 **Status**: COMPLETED **Delivery**: 비강 (intranasal) **Enrollment**: 9 **Summary**: 비강 투여로 BBB 우회. 부작용 없음, 중간용량군에서 ADAS-cog 인지 개선. **Publication**: General Psychiatry 2023 **Tags**: alzheimers, exosome, intranasal, BBB, china --- ## RegenBrief ### 2026년 출간 논문으로 본 재생의료의 변화 **URL**: /regenbrief/2026-05-12-regenerative-medicine-trends-2026/ **Date**: 2026-05-12 **Summary**: 세포치료에서 secretome, EV, 전달 플랫폼으로 ### 줄기세포 치료는 노쇠를 개선할 수 있을까 **URL**: /regenbrief/2026-05-09-stem-cell-frailty-msc-clinical/ **Date**: 2026-05-09 **Summary**: CRATUS·Laromestrocel·Zhu 2024·Nguyen 2026까지 — 중간엽줄기세포 노쇠 임상의 근거와 한계 ### MSC 유래 엑소좀 기반 나노제형, 표적 항암치료의 차세대 약물전달 플랫폼으로 주목 **URL**: /regenbrief/2026-05-03-msc-exosome-nanoformulation-cancer/ **Date**: 2026-05-03 **Summary**: International Journal of Pharmaceutics 리뷰 논문, 항암제·RNA·면역조절 물질을 종양에 전달하는 생체 모방형 플랫폼 가능성 정리 / 현재 핵심 근거는 세포실험과 동물모델 중심이며, 임상 적용을 위해 표준화·대량생산·안전성 검증 필요 ### 줄기세포 치료의 핵심 쟁점, 왜 '면역원성'인가 **URL**: /regenbrief/2026-04-30-msc-immunogenicity-cell-source/ **Date**: 2026-04-30 **Summary**: 제대 유래 MSC의 낮은 면역원성은 강점이지만, 최적의 세포원은 질환과 치료 전략에 따라 달라진다 ### 엑소좀 피부 시술, 가능성은 커졌지만 기준은 아직 따라오지 못했다 **URL**: /regenbrief/2026-04-30-exosome-skin-microneedling/ **Date**: 2026-04-30 **Summary**: 마이크로니들링 병합요법, 탈모·피부노화·색소침착에서 초기 효과 보고…전문가들 '원료·제조·품질관리·규제 기준 확인이 핵심' ### 엑소좀, 우울증 진단과 치료의 새 가능성으로 주목 **URL**: /regenbrief/2026-04-29-exosome-depression/ **Date**: 2026-04-29 **Summary**: Molecular Psychiatry 리뷰 논문, 엑소좀이 신경염증·시냅스 가소성·장-뇌 축을 연결하는 핵심 매개체일 가능성 제시 --- ## Policy Analysis ### 일본 재생의료 임상 및 제품 개발 현황 기술통계 보고서 **URL**: /stat/2026-03-31-japan-regen-clinical-stats/ **Date**: 2026-03-31 ### 첨단재생의료 임상연구 적합·승인 현황 기술통계 보고서 **URL**: /stat/2026-03-31-advanced-regenmed-approval-stats/ **Date**: 2026-03-31 --- ## Controlled Vocabularies ### Indication IDs - `alzheimers-disease` — 알츠하이머병 (Alzheimer's Disease) - `mild-cognitive-impairment` — 경도인지장애 (Mild Cognitive Impairment) - `parkinsons-disease` — 파킨슨병 (Parkinson's Disease) - `spinal-cord-injury` — 척수손상 (Spinal Cord Injury) - `als` — 근위축성측삭경화증 (Amyotrophic Lateral Sclerosis (ALS)) - `stroke` — 뇌졸중 (Stroke) - `knee-osteoarthritis` — 무릎 골관절염 (Knee Osteoarthritis) - `hip-osteoarthritis` — 고관절 골관절염 (Hip Osteoarthritis) - `cartilage-injury` — 연골 손상 (Cartilage Injury) - `intervertebral-disc-degeneration` — 추간판 변성 (Intervertebral Disc Degeneration) - `graft-versus-host-disease` — 이식편대숙주병 (Graft-versus-Host Disease (GvHD)) - `crohns-disease` — 크론병 (Crohn's Disease) - `lupus` — 전신홍반루푸스 (Systemic Lupus Erythematosus) - `type-1-diabetes` — 1형 당뇨병 (Type 1 Diabetes) - `myocardial-infarction` — 심근경색 (Myocardial Infarction) - `heart-failure` — 심부전 (Heart Failure) - `critical-limb-ischemia` — 중증하지허혈 (Critical Limb Ischemia) - `ards-covid` — 코로나19 ARDS (COVID-19 ARDS) - `bronchopulmonary-dysplasia` — 기관지폐이형성증 (Bronchopulmonary Dysplasia) - `liver-cirrhosis` — 간경변 (Liver Cirrhosis) - `chronic-kidney-disease` — 만성신질환 (Chronic Kidney Disease) - `dystrophic-epidermolysis-bullosa` — 이영양성 수포성 표피박리증 (Dystrophic Epidermolysis Bullosa) - `atopic-dermatitis` — 아토피 피부염 (Atopic Dermatitis) - `wound-healing` — 창상 치유 (Wound Healing) - `hair-loss` — 탈모 (Hair Loss / Alopecia) - `skin-rejuvenation` — 피부 재생 (Skin Rejuvenation) ### Cell Source IDs - `wj-msc` — 와튼젤리 중간엽줄기세포 (WJ-MSC) · family: msc - `uc-msc` — 제대 중간엽줄기세포 (UC-MSC) · family: msc - `bm-msc` — 골수 중간엽줄기세포 (BM-MSC) · family: msc - `ad-msc` — 지방 중간엽줄기세포 (AD-MSC) · family: msc - `placenta-msc` — 태반 중간엽줄기세포 (PL-MSC) · family: msc - `msc-exosome` — MSC 유래 엑소좀 (MSC-Exo) · family: exosome - `wj-msc-exosome` — WJ-MSC 유래 엑소좀 (WJ-MSC-Exo) · family: exosome - `ad-msc-exosome` — 지방 MSC 유래 엑소좀 (AD-MSC-Exo) · family: exosome - `platelet-exosome` — 혈소판 유래 엑소좀 (Plt-Exo) · family: exosome - `msc-secretome` — MSC 분비체 (MSC-Sec) · family: secretome - `ipsc` — 유도만능줄기세포 (iPSC) · family: pluripotent - `esc` — 배아줄기세포 (ESC) · family: pluripotent - `nsc` — 신경줄기세포 (NSC) · family: tissue-specific - `hsc` — 조혈모세포 (HSC) · family: tissue-specific --- ## Machine-Readable Resources - **llms.txt** (AI agent index): /llms.txt - **skill.md** (capability declaration): /skill.md - **agent-permissions.json** (access rules): /agent-permissions.json - **sitemap.xml**: /sitemap.xml - **RSS feed**: /feed.xml - **AGENTS.md** (repo agent guide): https://github.com/jjgitson/dyphi-flc/blob/main/AGENTS.md