TABLE 1.
Current status and enrollment of MSC clinical trials*
| Phases, number of studies [targeted enrollment] |
|||||
|---|---|---|---|---|---|
| Targeted condition | I | I/II | II | II/III | III |
| Bone/cartilage disorders | |||||
| Bone cysts | 1 [6] | 1 [10] | |||
| Bone neoplasms | 1 [50] | ||||
| Cartilage defect | 1 [50] | 2 [38] | 1 [100] | ||
| Degenerative osteoarthritis | 2 [30] | 1 [25] | |||
| Distraction osteogenesis | 1 [6] | ||||
| Fractures | 2 [16] | 1 [24] | 1 [40] | ||
| Ligament injury | 1 [24] | 1 [10] | |||
| Meniscectomy | 2 [110] | ||||
| Osteoarthritis | 5 [42] | 2 [45] | 4 [222] | 1 [104] | |
| Osteodysplasia | 1 [8] | ||||
| Osteogenesis imperfecta | 1 [9] | ||||
| Osteonecrosis | 1 [21] | 2 [39] | 1 [10] | ||
| Osteoporosis | 1 [290] | ||||
| Pseudoarthrosis | 1 [50] | ||||
| Spinal fusion | 1 [62] | ||||
| Hematologic disorders | |||||
| Aplastic anemia | 2 [60] | 1 [30] | |||
| BMT | 1 [125] | 3 [40] | 3 [125] | ||
| GVHD | 2 [59] | 6 [130] | 6 [286] | 1 [100] | 1 [240] |
| Myelodysplastic syndrome | 1 [30] | ||||
| Diabetes | |||||
| Type 1 | 1 [24] | 5 [168] | 1 [60] | 1 [80] | |
| Type 2 | 1 [24] | 3 [170] | |||
| Liver diseases | |||||
| Autoimmune hepatitis | 1 [100] | ||||
| Cirrhosis | 3 [29] | 7 [715] | 5 [266] | ||
| Hypercholesterolemia | 1 [1] | ||||
| Liver failure | 2 [228] | 1 [120] | |||
| Liver transplant | 1 [40] | 1 [60] | |||
| Primary biliary cirrhosis | 1 [100] | ||||
| Cardiovascular diseases | |||||
| Dilated cardiomyopathy | 2 [66] | 2 [80] | |||
| Heart failure | 3 [172] | 4 [160] | |||
| Myocardial infarction | 1 [53] | 2 [45] | 2 [380] | 1 [80] | 2 [165] |
| Myocardial ischemia | 2 [144] | 3 [89] | 1 [60] | ||
| Gastrointestinal diseases | |||||
| Crohn’s disease | 3 [56] | 1 [10] | 4 [696] | ||
| Fistula in ano | 1 [10] | 1 [40] | |||
| Ulcerative colitis | 1 [50] | ||||
| Autoimmune or skin disorders | |||||
| Burns | 1 [20] | ||||
| Epidermolysis bullosa | 1 [75] | ||||
| HIV | 1 [36] | ||||
| SLE | 1 [20] | ||||
| Rheumatoid arthritis | 2 [203] | ||||
| Sjogren’s disease | 1 [20] | ||||
| Systemic sclerosis | 1 [20] | ||||
| Lung diseases | |||||
| Bronchopulmonary dysplasia | 3 [28] | ||||
| COPD | 1 [62] | ||||
| Emphysema | 1 [10] | ||||
| Idiopathic pulmonary fibrosis | 1 [8] | ||||
| Neuromuscular diseases | |||||
| ALS | 1 [25] | 1 [24] | 1 [30] | ||
| Alzheimer’s | 1 [9] | 1 [30] | |||
| Brain injury | 1 [2] | ||||
| Cerebellar ataxia | 1 [8] | 1 [20] | |||
| Disc disease | 3 [55] | ||||
| Hereditary ataxia | 1 [20] | ||||
| ICSOL hemorrhage | 1 [20] | ||||
| Limbus insufficiency | 1 [30] | ||||
| Multiple sclerosis | 1 [24] | 5 [103] | 1 [16] | ||
| Multiple sclerosis and NMO | 1 [20] | ||||
| Multiple system atrophy | 1 [27] | ||||
| Parkinson’s disease | 1 [20] | ||||
| Retinitis pigmentosa | 1 [10] | ||||
| Romberg’s disease | 1 [5] | ||||
| Spinal cord injury | 4 [53] | 2 [100] | 2 [90] | 1 [32] | |
| Stroke | 1 [30] | 3 [203] | 3 [100] | ||
| Muscular dystrophy | 1 [15] | ||||
| Neomyogenesis | 1 [30] | ||||
| Limb ischemia | |||||
| Diabetic foot | 1 [40] | 1 [30] | |||
| Limb ischemia | 9 [245] | 2 [176] | |||
| Renal diseases | |||||
| Kidney injury | |||||
| Kidney transplant | 3 [41] | ||||
| Lupus nephritis | 1 [20] | 1 [25] | |||
| Miscellaneous | |||||
| Endometriosis | 1 [60] | ||||
| Prostate cancer | 1 [31] | ||||
| Total: 218 [9757] | 42 [923] | 105 [3957] | 57 [3285] | 6 [367] | 8 [1225] |
*
The data were searched on the website of ClinicalTrials.gov (http://www.clinicaltrials.gov) on October 22, 2012. The following key words including “mesenchymal stem cells,” “mesenchymal stromal cells,” “multi-potent stromal cells,” “multi-potent progenitor cells,” “BM stromal cells,” and “connective tissue progenitor” were used.
ALS = amyotrophic lateral sclerosis; COPD = chronic obstructive pulmonary disease; HIV = human immunodeficiency virus; ICSOL = intracranial space–occupying lesion; NMO = neuromyelitis optica; SLE = systemic lupus erythematosus.