Table 2.
Clinical trials for injectable biomaterials in MI and PAD
| Material | Product Name (Identifier #) |
Trial Phase | MI/PAD | Study Design | Results | Ref. | |||
|---|---|---|---|---|---|---|---|---|---|
| Design | Control | Patient Population |
Delivery | ||||||
| Gelatin microspheres with bFGF | N/A | N/A | PAD | Non- randomized | None | Patients with CLI, no option of medical or surgical treatment (7 total) | Single intramuscular injection (200 μg) | Significant improvements in 6-minute walk distance, blood perfusion, transcutaneous oxygen pressure, and rest pain scale compared to pre-treatment values | (69) |
| Calcium crosslinked alginate hydrogel | Algisyl-LVR™ (NCT00847964) | I | MI | Non- randomized | None | HF patients (9 total) | Intramyocardial injections during cardiac bypass surgery or valve replacement/repai r (9–15 injections, 0.25–0.35 ml each) | Improved LV function and quality of life | (41) |
| Algisyl-LVR™ (NCT01311791) | II (AUGMENT-HF) | MI | Randomized, single-blind | Standard medical therapy alone | HF patients, approximately half with previous MI (78 patients) | Intramyocardial injections via limited left thoracotomy (10–19 injections, 0.3 ml each) | Significant increases in peak VO2 levels and 6- minute walk test distance, no changes in EF, LV end- diastolic diameter, or LV end- systolic diameter | (36,37) | |
| Calcium crosslinked alginate hydrogel | BL-1040 (NCT00557531) | I | MI | Non- randomized | None | Suffered moderate to large MI, underwent successful primary PCI (27 patients) | Catheter-based intracoronary infusion (2 ml) | Preserved LVEDV index, LVESV index, and LVEF | (40) |
| IK-5001 (NCT01226563) | II (PRESERVATION I) | MI | Randomized, double-blind | Placebo (Saline) | Suffered large MI, underwent successful primary PCI (303 patients) | Catheter-based intracoronary infusion (4 ml) | No differences in terms of LVEDV index | (39) | |
| Decellularized myocardial ECM hydrogel | VentriGel (NCT02305602) | I | MI | Non- randomized | None | Suffered previous MI, 60 days-3 years since event (18 patients projected) | Transendocardial delivery via MyoStar catheter | Ongoing | (20) |
bFGF, basic fibroblast growth factor; CLI, critical limb ischemia; ECM, extracellular matrix; EF, ejection fraction; HF, heart failure; LV, left ventricular; LVEDV, left ventricular end-diastolic volume; LVESV, left ventricular end-systolic volume; MI, myocardial infarction; PAD, peripheral artery disease; PCI, percutaneous coronary intervention