DiscGenics announced that the first 30 subjects have been safely treated in its first-in-human U.S. clinical study of IDCT, an allogeneic injectable disc cell therapy for mild to moderate degenerative disc disease. An independent data safety monitoring committee reported no safety issues and recommended that the trial continues with no changes to the protocol.
The prospective, randomized, double-blinded, vehicle- and placebo-controlled clinical study will enroll 60 patients in 14 centers across 12 states in the U.S. IDCT is being evaluated under an Investigational New Drug allowance and will be regulated as a drug/biologic through a therapeutic biologics license application. In 3Q19, FDA granted Fast Track designation for IDCT as a potential treatment option for chronic low back pain.
IDCT uses discogenic cells to yield a potential regenerative treatment for disc disease. Preclinical studies have shown that IDCT normalized disc architecture and restored disc height in animal models. If the same can be shown in humans, it could present an alternative to non-restorative, late-stage surgeries.
DiscGenics announced that the first 30 subjects have been safely treated in its first-in-human U.S. clinical study of IDCT, an allogeneic injectable disc cell therapy for mild to moderate degenerative disc disease. An independent data safety monitoring committee reported no safety issues and recommended that the trial continues with no changes to...
DiscGenics announced that the first 30 subjects have been safely treated in its first-in-human U.S. clinical study of IDCT, an allogeneic injectable disc cell therapy for mild to moderate degenerative disc disease. An independent data safety monitoring committee reported no safety issues and recommended that the trial continues with no changes to the protocol.
The prospective, randomized, double-blinded, vehicle- and placebo-controlled clinical study will enroll 60 patients in 14 centers across 12 states in the U.S. IDCT is being evaluated under an Investigational New Drug allowance and will be regulated as a drug/biologic through a therapeutic biologics license application. In 3Q19, FDA granted Fast Track designation for IDCT as a potential treatment option for chronic low back pain.
IDCT uses discogenic cells to yield a potential regenerative treatment for disc disease. Preclinical studies have shown that IDCT normalized disc architecture and restored disc height in animal models. If the same can be shown in humans, it could present an alternative to non-restorative, late-stage surgeries.
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