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Biomedical subjects

Ravi N Samy

Publications and source records attributed to Ravi N Samy.

8 recordsLinked to original sources
PubMed2026

A translational framework for early-phase inner-ear gene therapy: clinical trial design, regulatory strategy, and ethical considerations.

PURPOSE OF REVIEW: Hereditary hearing loss has historically been approached as a diagnostic category rather than a therapeutically modifiable disease. Recent advances in molecular genetics, cochlear gene delivery, and first-in-human clinical trials are changing that. This review summarizes contemporary progress in the genetics of hearing loss, with emphasis on emerging gene-based therapies, clinical trial design, regulatory and ethical considerations, and practical implications for otolaryngologists as biologic treatment enters clinical practice. RECENT FINDINGS: Early clinical trials targeting OTOF -related DFNB9 deafness have demonstrated satisfactory safety profiles and meaningful auditory recovery, establishing the first proof-of-concept for cochlear gene therapy in humans, culminating in the April 2026 FDA approval of Otarmeni. Genetic diagnoses are increasingly informing prognosis, cochlear implant counseling, and therapeutic candidacy. Preclinical research continues to expand toward recessive, dominant, and syndromic hearing loss using gene replacement, antisense, RNA interference, and genome-editing strategies. Substantial challenges remain, including heterogeneous outcome measures, uncertain long-term efficacy, regulatory complexity, and inequitable global access. SUMMARY: The genetics of hearing loss is transitioning from a diagnostic modality to an interventional one. Widespread clinical impact will require advances in vector engineering, equitable implementation, multidisciplinary counseling, and integration with established rehabilitation pathways. For otolaryngologists, genetic literacy is becoming essential to contemporary hearing care.

Humans↗
PubMed2006

Revision ossiculoplasty.

Although ossiculoplasty, also known as ossicular chain reconstruction (OCR), was attempted initially in the early 1900s, it was not until the 1950s that it became commonplace and relatively well understood. Since then, there have been numerous technologic advances and a gain in the understanding of ossiculoplasty. However, successful OCR with resulting long-term stability can be a daunting task. Typically, the most common condition requiring revision OCR is chronic suppurative otitis media (COM) with or without cholesteatoma. Primary and revision OCR are performed also for blunt and penetrating trauma-induced conductive hearing loss, congenital defects (eg, atresia), and benign and malignant tumors. Typically, reconstruction in ears with COM is more difficult than in ears without infection. This article discusses the key factors involved in successful revision OCR.

Ear Diseases↗
PubMed2006

Delayed extrusion of hydroxyapatite after transpetrosal reconstruction.

OBJECTIVES: : To review the long-term results of hydroxyapatite closure of transpetrosal defects. STUDY DESIGN: : Retrospective chart review. METHODS: : One hundred seventy-seven patients were followed for more than 5 years. After surgical management by way of transpetrosal routes, hydroxyapatite was placed after medial wound closure with abdominal fat and before a three-layered lateral soft tissue closure. RESULTS: : Among this group of patients, three (1.7%) cerebrospinal fluid (CSF) leaks were encountered. None of these required re-operation. Delayed extrusion of hydroxyapatite with concomitant superficial wound infections have occurred in seven (4%) patients. All required operative re-intervention. CONCLUSIONS: : Hydroxyapatite has proven to be an effective material in the closure of skull base defects. Nevertheless, delayed extrusion of this agent can occur, resulting in the potential for morbidity and the need for operative re-intervention.

Adipose Tissue↗
PubMed2004

Management of pseudomeningocele following neurotologic procedures.

OBJECTIVES: A pseudomeningocele results from the escape of cerebrospinal fluid through a dural defect with trapping of subarachnoid fluid in surrounding soft tissue. The present study evaluates the incidence of pseudomeningocele following neurotologic procedures and delineates an algorithm for management. METHODS: A retrospective review of 375 consecutive patients undergoing neurotologic procedures at a single institution identified 17 patients with the postoperative complication of pseudomeningocele. RESULTS: The incidence of pseudomeningocele formation was 4.5% in the present study. Fourteen pseudomeningoceles resolved with nonoperative management including pressure dressing, bed rest, and lumbar spinal drainage. Three patients failed nonoperative management and required surgical procedures for resolution. All patients ultimately had resolution of their pseudomeningocele. CONCLUSION: Skull-base pseudomeningoceles occur as a complication following neurotologic procedures and can cause complications as they enlarge. The majority of these cases can be dealt with in a nonsurgical manner, but those failing to respond to conservative management should be considered for surgical intervention.

Adult↗
PubMed2004

T-cell prolymphocytic leukemia presenting as an ear canal mass.

OBJECTIVE: We discuss the first reported case of a chronic leukemia involving the external auditory canal. STUDY DESIGN: Case report and review of the literature (Medline, 1962-2003). METHODS AND RESULTS: An adult man in good health came to receive medical attention because of a sensation of aural fullness. Radiologic and physical examination demonstrated an ovoid soft tissue mass of the lateral external auditory canal that, after biopsy and flow cytometry studies, was found to be T-cell prolymphocytic leukemia. The patient presented with minimal disease in a highly symptomatic location, allowing early initiation of therapy and extending his life by nearly four times the average life expectancy for this aggressive chronic leukemia. CONCLUSION: Lymphomas of the external auditory canal are extremely rare neoplasms. Only a few cases have previously been reported, and all of the previous reports involve acute leukemias. This report indicates that chronic leukemias can present with otologic manifestations such as an external auditory canal mass.

Biopsy, Needle↗
PubMed2003

Neuroepithelial cysts of the middle ear.

Neuroepithelial cysts are lesions of the central nervous system that have previously been reported in cerebral parenchyma, in the spinal cord, and within the ventricles in association with the choroid plexus. We describe 2 cases of neuroepithelial cysts of the middle ear. One was diagnosed after surgery for a retraction pocket and chronic otitis media complicated by an intraoperative cerebrospinal fluid (CSF) leak. The other produced bilateral spontaneous CSF otorrhea and mimicked the presentation of arachnoid granulations. Both cases were verified with immunohistochemical stains. Neuroepithelial cysts, although rare, should be considered in the differential diagnosis of spontaneous CSF otorrhea or an epitympanic mass.

Aged↗
PubMed2002

Effect of blood transfusion in an experimental sarcoma model.

OBJECTIVE: To study the effect of allogeneic, syngeneic, and autologous blood transfusion on the growth rate of the KHT tumor in a C3H murine model. DESIGN: Prospective, randomized, and controlled animal study. SUBJECTS: Sixty-one C3H female mice. INTERVENTIONS: The C3H female mice were implanted with 2 x 10(5) cells of KHT, a murine sarcoma. Ten days later, 0.3 mL of blood was removed from a retro-orbital site to simulate surgical blood loss. This blood loss was replaced by blood transfusion through a tail vein with the use of allogeneic (major histocompatibility complex incompatible), syngeneic (major histocompatibility complex compatible), or autologous blood. Tumor growth was measured daily for 14 days. The tumor growth curve for each of the animals was constructed and the mean slope of growth calculated for each group. RESULTS: There were statistically significant differences in tumor growth rate (P =.001) when the allogeneic group (mean slope = 0.232, n = 14), the syngeneic group (mean slope = 0.190, n = 17), and the autologous group (mean slope = 0.202, n = 14) were compared. A t test confirmed that there was no significant difference in the tumor growth rate between the groups transfused with syngeneic and autologous blood (P =.26). However, the rate of tumor growth in the allogeneic group was found to be significantly higher when independently compared with the syngeneic group (P<.001) and the autologous group (P =.02). CONCLUSIONS: In this experimental model of a solid murine sarcoma, allogeneic blood transfusion was associated with an increased rate of tumor growth compared with syngeneic and autologous blood transfusion, likely reflecting immunomodulatory effects incurred by the introduction of major histocompatibility complex-incompatible antigens.

Animals↗