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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test whether it is safe and feasible to transplant spermatogonial stem cells in order to restore fertility for men who have had their testicular tissue frozen prior to gonadotoxic therapy.
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.Check my eligibility
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.See study design
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 belowSelect...
I have my testicular tissue/cells stored for future use due to a treatment that could cause infertility.
Select...
My doctor has approved me for a stem cell transplant after finishing my primary treatment.
Select...
I am a male and my body is at least in mid-puberty.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with return of spermatogenesis
Secondary outcome measures
Number of participants with cancer recurrence
Number of participants with surgical complications of SSC transplantation and testicular tissue grafting
Trial Design
1Treatment groups
Experimental Treatment
Group I: Spermatogonial Stem Cell Transplant & Testicular Tissue GraftExperimental Treatment1 Intervention
Stem cell transplantation Testicular tissue grafting
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,720 Previous Clinical Trials
16,342,801 Total Patients Enrolled
Kyle E Orwig, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of leukemia, lymphoma, testicular cancer, or cancer that affected my testicles.I have my testicular tissue/cells stored for future use due to a treatment that could cause infertility.You have a mental or emotional condition that stops you from fully understanding the study and giving informed consent.My doctor has approved me for a stem cell transplant after finishing my primary treatment.I am healthy enough to be put under anesthesia.I am a male and my body is at least in mid-puberty.I am at high risk for complications if I undergo surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Spermatogonial Stem Cell Transplant & Testicular Tissue Graft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the patient enrollment total for this research project?
"Affirmative, the information made available on clinicaltrials.gov points to this medical trial actively seeking participants. The study was first published on March 1st 2023 and most recently updated on December 1st 2022 with a goal of recruiting 10 people from one site."
Answered by AI
Has enrollment opened for this research trial yet?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical research is currently enrolling participants; the trial was first published on March 1st 2023 and most recently updated on December 1st 2022, seeking to recruit 10 patients at a single site."
Answered by AI
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