Immune System Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Autoimmune Diseases

Infertility

Testicular biopsy is performed to obtain testicular tissue for cryopreservation

Testicular biopsy

Rachel Neelley

Kyle Orwig, PhD

Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.

Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Semen cryopreservation is an established fertility preserving therapy, but is not accessible or appropriate for all men. Currently there are no therapies to preserve the future fertility of preadolescent boys. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means of fertility preservation.

This study will harvest testicular tissue from eligible patients. Separate portions of the harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and maintained for participating patients as a resource for future elective procedures to attempt fertility restoration.

Testicular Tissue Cryopreservation for Fertility Preservation

Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens

The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.

A segment of testicular specimen (\~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining

Children's National Research Institute

Children's Hospital of Orange County

Children's Hospital Medical Center, Cincinnati

Ann & Robert H Lurie Children's Hospital of Chicago

Medical College of Wisconsin

Connecticut Children's Medical Center

Nationwide Children's Hospital

Washington University School of Medicine

Alfred I. duPont Hospital for Children

University of Miami

University of Chicago

Cook Children's Medical Center

Helen DeVos Children's Hospital

Seattle Children's Hospital

University of Texas

Oregon Health and Science University

Hackensack Meridian Health

Indiana University Health

University of Pittsburgh

Professor

Nervous System Diseases

Symptoms and General Pathology

Infections

Neoplasms

Rare Diseases

Epilepsy

Drug Resistant Epilepsy

Encephalitis

Seizures

Epilepsies, Partial

Limbic Encephalitis

Autoimmune Diseases of the Nervous System

Brain Diseases

Central Nervous System Diseases

Neurologic Manifestations

Neuroinflammatory Diseases

Virus Diseases

Central Nervous System Viral Diseases

Communicable Diseases

Central Nervous System Infections

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Neurodegenerative Diseases

All Drugs and Chemicals

Autoantibodies

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

IVIG 2 mg/kg in two divided doses with placebo crossover

IVIG

Charles M. Epstein, M.D.

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).

The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.

At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

The study is divided into two phases:

Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.

Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Baxter Healthcare Corporation

Emory University

Professsor of Neurology - Divsion of Epilepsy

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

No AE's.

All Subjects

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early. Subject eligibility for phase 2 not available.

Dr. Charles M. Epstein

No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.

Immune Abnormalities

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testicular Tissue Cryopreservation for Fertility Preservation	NCT02972801	Cancer Autoimmune Diso...	Testicular biop...	-	University of Pittsburgh
IVIG Treatment for Refractory Immune-Related Adult Epilepsy	NCT01545518	Epilepsy, Crypt... Epilepsy, Parti... Seizure Disorde... Autoimmune Dise... Limbic Encephal...	IVIG	18 Years - 50 Years	Emory University
Testicular Tissue Cryopreservation for Fertility Preservation	NCT02972801	Cancer Autoimmune Diso...	Testicular biop...	-	University of Pittsburgh

Spots Global Cancer Trial Database for autoimmune disorders