Statistical Report on Advanced Regenerative Medicine Clinical Research Authorization in South Korea
Analysis of 60 cases as of March 2026 — cell therapy dominant, oncology leads, concentrated in major tertiary hospitals
1. Overview of Analysis
This report provides a descriptive statistical summary of the distribution and structural characteristics of advanced regenerative medicine clinical research in South Korea, based on 60 research plans included in the “Status of Advanced Regenerative Medicine Research Plan Authorization and Approval (as of March 2026).” The items analyzed include research plan titles, implementing institutions, regenerative medicine classification, risk level, review/approval dates, CRIS registration numbers, target diseases, and treatment technologies.
This report does not evaluate the efficacy or safety of individual treatments. Its purpose is to understand the current state of the advanced regenerative medicine clinical research ecosystem in South Korea by cataloguing disease groups, treatment technologies, institution types, risk levels, and geographic distribution of research plans that have received authorization or approval.
2. Overall Summary
| Item | Result |
|---|---|
| Total number of research plans | 60 |
| Reference date | March 2026 |
| Most common regenerative medicine classification | Cell therapy: 42 cases |
| Most common risk level | High-risk: 24 cases, Moderate-risk: 24 cases |
| Most common disease group | Cancer/hematologic malignancy: 20 cases |
| Second most common disease group | Musculoskeletal: 10 cases |
| Explicitly multi-institutional studies | 6 cases |
| Studies with CRIS registration number | 45 cases |
| Studies without CRIS registration | 15 cases |
Overall, advanced regenerative medicine clinical research in South Korea is characterized by a cell therapy-centered, cancer/hematologic malignancy-centered, and major tertiary hospital-centered structure. At the same time, the scope of application is expanding into musculoskeletal, autoimmune, rare, neurological, tissue reconstruction, and age-related disease areas.
3. Annual Approval Trends
| Approval Year | Cases | Proportion |
|---|---|---|
| 2021 | 3 | 5.0% |
| 2022 | 7 | 11.7% |
| 2023 | 16 | 26.7% |
| 2024 | 15 | 25.0% |
| 2025 | 16 | 26.7% |
| 2026 | 3 | 5.0% |
| Total | 60 | 100.0% |
The number of approvals has increased notably since 2023. With 16 cases in 2023, 15 in 2024, and 16 in 2025, 47 of the total 60 cases are concentrated in the past three years. This suggests that advanced regenerative medicine clinical research in South Korea has moved beyond the early stage of regulatory implementation and is now expanding into actual research approval and conduct.
Since the 2026 figure covers only through March, direct comparison with full-year trends is difficult. However, 3 cases were approved within three months, so the cumulative total may continue to grow.
4. Distribution by Regenerative Medicine Classification
| Classification | Cases | Proportion |
|---|---|---|
| Cell therapy | 42 | 70.0% |
| Gene therapy | 8 | 13.3% |
| Tissue engineering | 5 | 8.3% |
| Convergence/combination | 5 | 8.3% |
| Total | 60 | 100.0% |
Cell therapy accounts for 70.0% of the total. Gene therapy comprises 8 cases (13.3%), most of which involve CAR-T or genetically engineered cell therapies. Tissue engineering and convergence/combination research account for 5 cases each, appearing primarily in conditions requiring structural tissue repair or reconstruction, such as radiation proctitis, Behcet’s enteritis, complex anal fistula, soft tissue defects, and tracheal regeneration.
5. Distribution by Risk Level
| Risk Level | Cases | Proportion |
|---|---|---|
| High-risk | 24 | 40.0% |
| Moderate-risk | 24 | 40.0% |
| Low-risk | 12 | 20.0% |
| Total | 60 | 100.0% |
High-risk and moderate-risk studies are equal at 24 cases each. High-risk studies include CAR-T, iPSC-derived cells, allogeneic stem cells, genetically engineered cells, and bioprinting. Low-risk studies frequently involve treatment technologies with autologous cells or limited manipulation, such as autologous SVF, autologous bone marrow concentrate, and autologous fat grafting.
6. Distribution by Disease Group
| Disease Group | Cases | Proportion | Representative Indications |
|---|---|---|---|
| Cancer/hematologic malignancy | 20 | 33.3% | Glioblastoma, pancreatic cancer, breast cancer, gastric cancer, lymphoma, leukemia |
| Musculoskeletal | 10 | 16.7% | Knee osteoarthritis, rotator cuff tear, spinal fusion, avascular necrosis of the femoral head, fracture |
| Rare/pediatric/neonatal diseases | 5 | 8.3% | Pediatric progeria, osteogenesis imperfecta, pulmonary hypertension in extremely preterm infants |
| Gastrointestinal/bowel diseases | 5 | 8.3% | Radiation proctitis, Behcet’s enteritis, complex anal fistula, liver cirrhosis |
| Autoimmune/immune diseases | 4 | 6.7% | Sjogren’s syndrome, SLE, atopic dermatitis |
| Cardiovascular/vascular diseases | 3 | 5.0% | Myocardial infarction, dilated cardiomyopathy, peripheral arterial disease |
| Infection/transplant-related | 3 | 5.0% | CMV retinitis, long COVID (SARS-CoV-2), post-hematopoietic stem cell transplant infection |
| Neurological diseases | 2 | 3.3% | Spinal cord injury, frontotemporal dementia |
| Women’s health/reproductive medicine | 2 | 3.3% | Premature ovarian insufficiency, intrauterine adhesion |
| Plastic/reconstructive/tissue defect | 2 | 3.3% | Enophthalmos, soft tissue defect |
| Sarcopenia/frailty-related | 1 | 1.7% | Age-related sarcopenia |
| Other | 3 | 5.0% | Diabetic nephropathy, diabetic foot ulcer, tracheal regeneration |
| Total | 60 | 100.0% |
Cancer and hematologic malignancies account for the largest share at 33.3%. Immune cell-based therapies such as NK cells, TIL, CAR-T, dendritic cells, and CIK cells appear repeatedly. Musculoskeletal disease is the second largest area, linked to the demand for functional recovery, pain management, and reconstruction driven by population aging.
Sarcopenia/frailty-related research accounts for just 1 case. However, when fractures, osteoarthritis, rotator cuff disease, and frontotemporal dementia are included, disease groups closely associated with the elderly population represent a substantial share.
7. Characteristics by Treatment Technology and Cell Source
| Treatment Technology / Cell Source | Key Application Areas | Characteristics |
|---|---|---|
| Autologous SVF / adipose-derived cells | Musculoskeletal, plastic/reconstructive, premature ovarian insufficiency, anal fistula | Frequently classified as low-risk or moderate-risk |
| Autologous bone marrow-derived cells / BMAC | Cardiovascular, fracture, intrauterine adhesion, liver cirrhosis | Relatively established autologous cell-based approach |
| Allogeneic umbilical cord-derived MSC | Musculoskeletal, neurological, rare diseases, respiratory | Frequently classified as high-risk |
| iPSC-derived cells | Knee osteoarthritis, peripheral arterial disease | Next-generation cell therapy platform; predominantly high-risk |
| NK cells | Pancreatic cancer, lung cancer, liver cancer, glioblastoma | Major pillar of anti-cancer immune cell therapy |
| TIL | Melanoma, ovarian cancer | Tumor-specific immune cell therapy used in solid tumors |
| CAR-T | Leukemia, lymphoma, SLE | Mostly classified as high-risk gene therapy |
| Dendritic cells / DC | Pancreatic cancer | Cancer vaccine and combination strategy with immune checkpoint inhibitors |
| Tissue engineering / bioprinting | Proctitis, enteritis, anal fistula, tracheal regeneration | Focused on tissue damage and reconstruction |
Technology platforms can be organized into three axes. First, low-risk and moderate-risk regenerative therapies using autologous SVF and bone marrow-derived cells. Second, immune cell-based anti-cancer therapies using NK cells, TIL, CAR-T, CIK cells, and dendritic cells. Third, high-risk advanced platforms including iPSC, allogeneic MSC, genetically engineered cells, and bioprinting.
8. Increase in Combination Therapies
In the oncology area, combination studies with existing standard-of-care treatments are more prominent than simple cell infusion alone.
| Combination Type | Example Diseases | Interpretation |
|---|---|---|
| Immune cells + chemotherapy | Glioblastoma, pancreatic cancer, liver cancer | Aimed at supplementing response rate or durability of existing chemotherapy |
| Immune cells + radiation therapy | Glioblastoma | Combined with standard chemoradiation |
| Dendritic cells + immune checkpoint inhibitors | Metastatic pancreatic cancer | Aimed at enhancing anti-tumor immune response |
| CAR-T followed by subsequent CAR-T or re-treatment | Lymphoma | Targeting patients who relapsed or were refractory after prior CAR-T exposure |
| Cell therapy + surgery | Rotator cuff tear, spinal fusion, fracture | Aimed at supporting post-surgical regeneration and recovery |
This demonstrates that advanced regenerative medicine in oncology is being developed as a complementary or combination treatment strategy that supplements rather than replaces existing standard-of-care.
9. Characteristics by Hospital Classification
| Hospital Classification | Key Characteristics |
|---|---|
| Tertiary general hospitals | Concentration of high-risk, gene therapy, CAR-T, iPSC, and allogeneic cell studies |
| University hospitals / general hospitals | Mix of cell therapy, oncology, musculoskeletal, and rare disease studies |
| Specialty hospitals | Focused on low-risk studies such as musculoskeletal, anal fistula, and autologous SVF |
| Clinics | Focused on specific indications such as premature ovarian insufficiency and diabetic nephropathy |
High-risk studies are concentrated in major tertiary hospitals such as Seoul National University Hospital, Samsung Seoul Hospital, Asan Medical Center Seoul, Severance Hospital, and Seoul St. Mary’s Hospital. In contrast, low-risk studies using autologous SVF, autologous bone marrow concentrate, and autologous fat grafting are partly conducted at specialty hospitals and clinics as well.
This suggests that advanced regenerative medicine may develop in a structure where high-risk gene and cell therapies remain centered in large hospitals, while autologous cell-based low-risk therapies have the potential to spread to a broader range of healthcare institutions.
10. Geographic Characteristics
| Region | Key Institutions and Characteristics |
|---|---|
| Seoul | Centered on major tertiary hospitals including Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center Seoul, Samsung Seoul Hospital, and Severance Hospital |
| Gyeonggi | Diverse institutional distribution including CHA Bundang Medical Center, Seoul National University Bundang Hospital, National Cancer Center, and Soonchunhyang University Bucheon Hospital |
| Incheon | Naeun Hospital, Inha University Hospital, International St. Mary’s Hospital — musculoskeletal, fracture, and rare disease research |
| South Jeolla / Gwangju | Centered on Hwasun Chonnam National University Hospital and Chonnam National University Hospital — cancer immunotherapy and cardiovascular research |
| Busan / South Gyeongsang | Centered on Dong-A University Hospital, Busan Port Second Hospital, and Yangsan Pusan National University Hospital — cancer, anal fistula, and rare disease research |
| Daejeon | Konyang University Hospital’s HER2+ breast cancer gene therapy research |
Concentration in the Seoul metropolitan area is high, but cancer, cardiovascular, and rare disease research is also confirmed at non-metropolitan institutions such as Hwasun Chonnam National University Hospital, Chonnam National University Hospital, Dong-A University Hospital, and Yangsan Pusan National University Hospital.
11. Multi-Institutional Research Overview
The source data identifies 6 studies that explicitly involved two or more institutions.
| No. | Indication | Implementing Institutions | No. of Institutions |
|---|---|---|---|
| 2 | Moderate-to-severe atopic dermatitis | Seoul National University Bundang Hospital / ID Hospital | 2 |
| 7 | Partial-thickness rotator cuff tear | Asan Medical Center Seoul / Boramae Hospital | 2 |
| 26 | Large and massive rotator cuff tear | Korea University Anam Hospital / Boramae Hospital | 2 |
| 33 | CD19-positive B-cell acute lymphoblastic leukemia | Seoul National University Hospital / Seoul St. Mary’s Hospital / Asan Medical Center Seoul / Samsung Seoul Hospital / Severance Hospital | 5 |
| 40 | Soft tissue defect following benign tumor resection | Seoul National University Hospital / St. Vincent’s Hospital / Hanyang University Hospital | 3 |
Multi-institutional research reflects a pattern in which inter-institutional collaboration is used for conditions where participant recruitment is difficult or where generalizability of results needs to be improved.
12. CRIS Registration Status
| CRIS Registration | Cases | Proportion |
|---|---|---|
| Registered (number provided) | 45 | 75.0% |
| Not registered or not stated | 15 | 25.0% |
| Total | 60 | 100.0% |
45 of the 60 cases (75.0%) have a CRIS registration number recorded. Rather than concluding that missing CRIS entries indicate a lack of research transparency, it is important to also consider the possibility of an administrative or operational time lag between approval and the actual commencement of the study.
13. Key Cross-Analysis Insights
| Cross-Analysis | Observed Findings |
|---|---|
| Regenerative medicine classification × risk level | Gene therapy is mostly high-risk; cell therapy is distributed across low-, moderate-, and high-risk categories |
| Disease group × treatment technology | Cancer primarily uses immune cell-based therapies (NK, TIL, CAR-T); musculoskeletal primarily uses SVF, MSC, and iPSC-derived chondrocytes |
| Hospital classification × risk level | High-risk is centered in tertiary hospitals; low-risk is partly conducted at hospitals and clinics |
| Year × number of approvals | Approvals increased significantly from 2023 onward |
| Treatment technology × institution type | Autologous SVF and bone marrow concentrate extend to hospital-level institutions; CAR-T and iPSC are centered in large hospitals |
| Treatment strategy × standard care | In oncology, combination with chemotherapy, radiation, and immune checkpoint inhibitors is more prominent than standalone cell therapy |
14. Policy and Industry Implications
Cell therapy-centered growth. Of the 60 total cases, 42 are cell therapy, with diverse platforms including stem cells, immune cells, bone marrow-derived, and adipose-derived cells coexisting.
Cancer and hematologic malignancy research holds the largest share. Immune cell-based therapies — CAR-T, NK cells, TIL, CIK cells, and dendritic cells — are the primary platforms. Advanced regenerative medicine is being actively applied not only in regenerative therapy but also in anti-cancer immunotherapy.
Musculoskeletal disease is a major area of expansion. At 10 cases (16.7% of total), the applicable scope is growing in the areas of musculoskeletal functional decline, pain, and reconstruction, where demand is increasing alongside population aging.
High-risk studies are concentrated in major tertiary hospitals. CAR-T, iPSC, allogeneic MSC, and genetically engineered cell therapies require advanced infrastructure and specialized personnel and are therefore conducted predominantly in large hospitals.
Low-risk autologous cell studies can expand to specialty hospitals and clinics. Autologous SVF, bone marrow concentrate, and fat grafting are conducted not only in tertiary hospitals but also in specialty hospitals, general hospitals, and clinics.
Combination therapies will be a key future research strategy. In oncology, advanced regenerative medicine is validating its clinical value in a direction that supplements rather than replaces existing standard-of-care.
15. Caveats for Interpreting This Report
| Limitation | Explanation |
|---|---|
| Analysis based on research plans | Actual patient recruitment, study completion, and publication of results are not reflected |
| Limitations of institution classification | Hospital classification is a practical classification based on institution names; official designation status requires separate verification |
| Subjectivity in disease group classification | Some studies span multiple categories; classification was based on the primary indication |
| Limitations of CRIS interpretation | Missing CRIS entries may reflect non-registration, delayed registration, or data not yet updated |
| Not an assessment of efficacy or safety | Does not imply treatment efficacy or clinical validity |
16. Conclusion
As of March 2026, advanced regenerative medicine clinical research in South Korea is characterized by a cell therapy-centered, cancer/hematologic malignancy-centered, and major tertiary hospital-centered structure. The figures of 42 cell therapy cases, 20 cancer/hematologic malignancy cases, and 24 each of high-risk and moderate-risk cases summarize this structure.
In terms of technology platforms, three approaches coexist: autologous cell-based low-risk regenerative therapy; NK/TIL/CAR-T-centered anti-cancer immune cell therapy; and iPSC, allogeneic MSC, and bioprinting-based high-risk advanced therapies. In oncology, advanced regenerative medicine is evolving toward combination with existing standard-of-care, suggesting that regenerative medicine is establishing itself as a clinical strategy that complements and strengthens the existing treatment paradigm.
This data can serve as an early ecosystem indicator showing which disease groups, technology platforms, and hospital ecosystems drive the development of advanced regenerative medicine clinical research in South Korea. Going forward, analysis should be extended to include actual patient recruitment status, study completion, publication of results, safety reporting, and commercialization prospects.