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128 results on '"Schranck, Francine W."'

2. Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration--Results of an FDA- Approved Biologic Therapy Randomized Clinical Trial.

Author

GORNET, MATTHEW F., BEALL, DOUGLAS P., DAVIS, TIMOTHY T., CORIC, DOMAGOJ, LABAGNARA, MICHAEL, KRULL, ANGELA, DEPALMA, MICHAEL J., HSIEH, PATRICK C., MALLEMPATI, SRINIVAS, SCHRANCK, FRANCINE W., KELLY, COLLEEN, and FOLEY, KEVIN T.

Subjects
PROGENITOR cells, LUMBAR vertebrae diseases, DEGENERATION (Pathology), LUMBAR vertebrae, DRUG efficacy, IMMUNOREGULATION, PLACEBOS, BACKACHE
Abstract

Background: Progenitor cells derived from intervertebral disc tissue demonstrated immunomodulatory and regenerative properties in preclinical studies. We report the safety and efficacy results of a Us Food and Drug Administration-approved clinical trial of these cells for the treatment of symptomatic degenerative disc disease. Methods: sixty patients with symptomatic single-level lumbar degenerative disc disease (mean age 37.9 years, 60% men) were enrolled in a randomized, double-blinded, placebo-controlled Phase I/Phase II study at 13 clinical sites. They were randomized to receive single intradiscal injections of either low-dose cells (N = 20), high-dose cells (N = 20), vehicle alone (N = 10), or placebo (N = 10). The primary endpoint was mean visual analog scale (VAs) pain improvement >30% at 52 weeks. Disc volume was radiologically assessed. Adverse events (AEs), regardless of whether they were related to treatment, were reported. Patients were assessed at baseline and at 4, 12, 26, 52, 78, and 104 weeks posttreatment. Results: At week 52, the high-dose group had a mean VAs percentage decrease from baseline (-62.8%, P = 0.0005), achieving the endpoint of back pain improvement >30%; the mean change was also significantly greater than the minimal clinically important difference of a 20-point decrease (-42.8, P = 0.001). This clinical improvement was maintained at week 104. The vehicle group had a smaller significant decrease in VAs (-52.8%, P = 0.044), while the low-dose and placebo groups showed nonsignificant improvements. Only the high-dose group had a significant change in disc volume, with mean increases of 249.0 mm3 (P = 0.028) at 52 weeks and 402.1 mm3 (P = 0.028) at 104 weeks. A minority of patients (18.3%) reported AEs that were severe. Overall, 6.7% of patients experienced serious AEs, all in the vehicle (n = 1) or placebo (n = 3) groups, none treatment related. Conclusions: High-dose allogeneic disc progenitor cells produced statistically significant, clinically meaningful improvements in back pain and disc volume at 1 year following a single intradiscal injection and were safe and well tolerated. These improvements were maintained at 2 years post-injection. Level of Evidence: 1. Clinical Trial Registration: NCT03347708--study to Evaluate the safety and Preliminary Efficacy of Injectable Disc Cell Therapy, a Treatment for symptomatic Lumbar Intervertebral Disc Degeneration. [ABSTRACT FROM AUTHOR]

Published
2024
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18. 250. Interspinous process distraction compared to nonoperative care for moderate lumbar degenerative disc disease: results of the FDA IDE clinical trial

Author

Gornet, Matthew F., primary, Bailey, Alexander S., additional, Eltahawy, Hazem A., additional, Sasso, Rick C., additional, Cheng, Wayne K., additional, Palmer, Sylvain, additional, Dohring, Edward J., additional, Taha, Jamal, additional, Schranck, Francine W., additional, and Copay, Anne G., additional

Published
2019
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21. Supplemental Material, activL_5-year_Meta-analysis_Manuscript-Supplemental-Mar_9_2017 - Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials

Author

Zigler, Jack, Gornet, Matthew F., Ferko, Nicole, Cameron, Chris, Schranck, Francine W., and Patel, Leena

Subjects
FOS: Clinical medicine, 110323 Surgery, 110604 Sports Medicine, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases, 110314 Orthopaedics
Abstract

Supplemental Material, activL_5-year_Meta-analysis_Manuscript-Supplemental-Mar_9_2017 for Comparison of Lumbar Total Disc Replacement With Surgical Spinal Fusion for the Treatment of Single-Level Degenerative Disc Disease: A Meta-Analysis of 5-Year Outcomes From Randomized Controlled Trials by Jack Zigler, Matthew F. Gornet, Nicole Ferko, Chris Cameron, Francine W. Schranck, and Leena Patel in Global Spine Journal

Published
2017
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22. Significant developmental elevation in serum parathyroid hormone levels in a large kindred with familial benign (hypocalciuric) hypercalcemia

Author

McMurtry, Cynthia T., Schranck, Francine W., Walkenhorst, Denise A., Murphy, William A., Kocher, David B., Tietelbaum, Steven L., Rupich, Reta C., and Whyte, Michael P.

Subjects
Parathyroid hormone -- Physiological aspects, Hypercalcemia -- Physiological aspects, Osteomalacia -- Development and progression, Hypophosphatemia -- Complications, Health, Health care industry
Published
1992

23. Hypercalciuria in children severely affected with osteogenesis imperfecta

Author

Chines, Arkadi, Petersen, Deborah J., Schranck, Francine W., and Whyte, Michael P.

Subjects
Osteogenesis imperfecta -- Complications, Osteogenesis imperfecta -- Physiological aspects, Hypercalciuria -- Causes of, Health
Abstract

To learn more about mineral metabolism in children with osteogenesis imperfecta (OI), an inherited disorder that affects connective tissue, the cases of 47 OI patients treated at one medical facility were reviewed. (Connective tissue is the supportive tissue that is an integral part of every organ in the body.) Of particular concern were the concentrations of calcium and enzymes related to calcium metabolism in the children's blood and urine, since OI is associated with increased bone fragility and more frequent bone fractures. (Calcium metabolism affects bone formation and strength.) Tests on blood and urine samples showed that 17 children (36 percent) had excessive levels of calcium in their urine (hypercalciuria). No differences were found between hypercalciuric and normocalciuric (normal urinary calcium levels) children in age, sex, or dietary intake of calcium, but hypercalciuric patients were shorter, weighed less, and had suffered more bone fractures. Hypercalciuric and normocalciuric children had similar levels of calcium and other minerals in the blood. A discussion is presented of the causes of hypercalciuria in children. The results suggest that children with OI should not be treated with calcium supplements or vitamin D (which affects calcium absorption) unless urinary calcium levels are first monitored and followed closely during treatment. Treatment should only begin after determining that the patient's diet is deficient in calcium. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

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