Immune System Diseases

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Autoimmune Diseases

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Infertility, Male

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Urogenital Diseases

Genital Diseases, Male

Male Urogenital Diseases

Stem cell transplantation Testicular tissue grafting

Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Rachel Neelley

Kyle E Orwig, PhD

Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and testicular tissue grafting will be performed for participants who have frozen testicular tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and feasibility of these transplant technologies and restore fertility for these participants.

Azoospermia (no sperm in ejaculated semen) impacts 1% of men in the general population and 15% of infertile men, which translates to 645,000 males between the ages of 20 and 50 (prime reproductive years) in the United States. Spermatogenesis arises from a population of spermatogonial stem cells in the testes that maintain continuous sperm production throughout a man's post-pubertal life. Diseases or medical treatments that compromise the stem cell pool and/or prevent the stem cells from differentiating can cause infertility. Adult men have the option to cryopreserve a semen sample prior to therapy but this is not an option for prepubertal patients who are not yet producing sperm. This study will test the safety and feasibility of two approaches to restore sperm production using previously cryopreserved testicular tissues, which contain spermatogonial stem cells.

The first approach is autologous transplantation of testicular cells, including spermatogonial stem cells, into the testis using ultrasound-guided rete testis injection. The second approach is autologous grafting of intact pieces of testicular tissue under the skin in the scrotum.

Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

The investigators will publish individual participant data, after deidentification. 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.

Rate of participants where sperm was found in semen analysis or testicular tissue analysis

Rate of participants diagnosed with cancer recurrence

Rate of infection, hospital readmission, re-operation occurs

University of Pittsburgh

Professor

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Communicable Diseases

Lymphoma, B-Cell

HTLV-I Infections

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Peripheral T-cell Lymphoma

B-cell Lymphoma

Human T-cell Leukemia Virus Type 1

Suspected or known disorder of the immune system or cancer; or, known or potential carrier of autoimmune disorder or immunodeficiency disease.

Kevin C Conlon, M.D.

This protocol is being submitted to consolidate, update, and expand two previously approved protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders. The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses, and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens. Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders. Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal, unrelated individuals will also be studied. A small number of procedures will be used including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall antigens and immunization to assess humoral immunity....

Background:

* The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years.
* Blood obtained by apheresis or blood drawing, skin biopsies and other tissues will be evaluated for abnormalities related to immunity, HTLV-1 infection and the immune system.
* Advances in the characterization of acquired genetic changes in tumor samples has

led to insights for the development of targeted therapy of malignancy

Objectives:

* To characterize the molecular biology and immunological features as well as the clinical course of individuals with suspected or known disorders of the immune system or cancer
* To define the nature of the immunological, genetic and epigenetic abnormalities in the cells of patients with immunodeficiency diseases associated with infections and/or a high incidence of malignancy and in patients with cancer.
* To obtain whole blood, plasma and leukocytes, as well as skin, lymph node and bone marrow biopsies on patients with immunodeficiency or cancer to investigate the immune system.

Eligibility:

* Subjects with cancer.
* Subjects with immunodeficiency.
* Subjects with HTLV-1 infection.

Design:

-This is a natural history study that permits tissue acquisition for analysis of the immune system and HTLV-1 infection.

Whole blood, serum, tissue, bone marrow aspirate and biopsy

Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer

Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection

.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. @@@@@@All collected IPD will be shared with collaborators under the terms of collaborative agreements.

No statistical endpoints are identified for this study; the purpose of the study is to acquire information regarding various immunodeficiency syndromes, HTLV-1 infection and malignancies. The data collected will not be combined for a summary report of the entire study; however, reports for specific disease entities may be published.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting	NCT04452305	Infertility, Ma... Cancer Autoimmune Diso...	Spermatogonial ...	-	University of Pittsburgh
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting	NCT04452305	Infertility, Ma... Cancer Autoimmune Diso...	Spermatogonial ...	-	University of Pittsburgh
Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer	NCT00001582	T-cell Lymphoma B-Cell Lymphoma ATL Myeloma		18 Years -	National Institutes of Health Clinical Center (CC)

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