What is the mechanism of action of this treatment?

Spermatogonial stem cell transplantation and testicular tissue grafting aim to restore fertility by reintroducing healthy spermatogonial stem cells into the testes, where they can differentiate into mature sperm cells. This is particularly important for patients who have undergone gonadotoxic therapies, such as chemotherapy, which can damage or destroy their own spermatogonial stem cells. By transplanting these cells, either from the patient before treatment or from a donor, the goal is to re-establish spermatogenesis, enabling natural conception or assisted reproductive techniques like intracytoplasmic sperm injection (ICSI). This approach offers a potential solution to restore fertility even after significant gonadal damage, providing hope for biological parenthood.

What side effects are associated with this type of intervention?

Common treatments for male infertility, such as spermatogonial stem cell transplantation and testicular tissue grafting, aim to restore fertility by reintroducing spermatogonial stem cells. Known side effects of these treatments can include surgical risks such as infection, bleeding, and pain at the site of tissue extraction or grafting. Additionally, there may be risks associated with anesthesia. Long-term effects are still being studied, but there is potential for unsuccessful grafting or transplantation, which may not restore fertility. Other treatments like hormone therapy can cause side effects such as mood swings, acne, and changes in libido.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals or related drugs for the treatment of male infertility using spermatogonial stem cell transplantation and testicular tissue grafting in the provided context. Generally, treatments for male infertility have included hormonal therapies, medications to improve sperm production, and assisted reproductive technologies such as in vitro fertilization (IVF). Experimental approaches like spermatogonial stem cell transplantation are still under investigation and have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to Spermatogonial Stem Cell Transplantation and Testicular Tissue Grafting for male infertility patients include: 1) In vitro spermatogenesis, where sperm cells are generated from stem cells in a laboratory setting; 2) Gene editing technologies like CRISPR-Cas9 to correct genetic defects causing infertility; 3) Advanced assisted reproductive technologies (ART) such as Intracytoplasmic Sperm Injection (ICSI) using spermatids or immature sperm cells; 4) Hormonal therapies to stimulate endogenous spermatogenesis in cases of hypogonadotropic hypogonadism.

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Stem Cell Therapy

SSC Transplant + Testicular Tissue Grafting for Male Infertility

N/A

Recruiting

Led By Kyle E Orwig, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously cryopreserved and stored testicular tissue/cells (frozen due to an infertility-risking diagnosis or treatment such as chemotherapy or radiation) available for autologous transplantation and grafting

Written clearance for the procedure from the patient's hematologist or oncologist to confirm the patient has finished treatment for primary condition and are clear to undergo autologous stem cell transplant

Must not have

Participants with a history of leukemia, lymphoma or testicular cancer or a cancer that likely involved testicles at the time of testicular tissue collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two methods to help men who stored testicular tissue before harmful treatments. It aims to restore their ability to produce sperm by reintroducing essential cells into their testes.

Who is the study for?

This trial is for males who have frozen their testicular tissue before undergoing treatments that could cause infertility, like chemotherapy or radiation. They must be healthy enough for anesthesia and past Tanner stage 3 of puberty. Those with a history of certain cancers or conditions affecting consent are not eligible.

What is being tested?

The study tests the safety and feasibility of restoring fertility through spermatogonial stem cell transplant and testicular tissue grafting in participants who've had gonadotoxic therapy.

What are the potential side effects?

Potential side effects may include complications from surgery or anesthesia, pain at injection or graft sites, infection risk, and possible immune reactions to transplanted cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have my testicular tissue/cells stored for future use due to a treatment that could cause infertility.

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My doctor has approved me for a stem cell transplant after finishing my primary treatment.

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I am a male and my body is at least in mid-puberty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of leukemia, lymphoma, testicular cancer, or cancer that affected my testicles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with return of spermatogenesis

Secondary study objectives

Number of participants with cancer recurrence

Number of participants with surgical complications of SSC transplantation and testicular tissue grafting

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Spermatogonial Stem Cell Transplant & Testicular Tissue GraftExperimental Treatment1 Intervention

Stem cell transplantation Testicular tissue grafting

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Spermatogonial stem cell transplantation and testicular tissue grafting aim to restore fertility by reintroducing healthy spermatogonial stem cells into the testes, where they can differentiate into mature sperm cells. This is particularly important for patients who have undergone gonadotoxic therapies, such as chemotherapy, which can damage or destroy their own spermatogonial stem cells. By transplanting these cells, either from the patient before treatment or from a donor, the goal is to re-establish spermatogenesis, enabling natural conception or assisted reproductive techniques like intracytoplasmic sperm injection (ICSI). This approach offers a potential solution to restore fertility even after significant gonadal damage, providing hope for biological parenthood.

Sertoli cell ablation and replacement of the spermatogonial niche in mouse.Hormonal suppression restores fertility in irradiated mice from both endogenous and donor-derived stem spermatogonia.Germ cell transplantation into X-irradiated monkey testes.