Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male participant at least in Tanner stage 3
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
Healthy enough to undergo anesthesia
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
Disqualifiers
Participants considered to be high risk for surgical complications
Participants with a history of leukemia, lymphoma or testicular cancer or a cancer that likely involved testicles at the time of testicular tissue collection
Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
Trial design
Design model
Single group
Treatments tested in this trial
Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting
Procedure/SurgerySpermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Spermatogonial Stem Cell Transplant & Testicular Tissue GraftExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with return of spermatogenesis
Rate of participants where sperm was found in semen analysis or testicular tissue analysis
Time frame
3 months-1yearSecondary outcomes
1
Number of participants with cancer recurrence
Rate of participants diagnosed with cancer recurrence
Time frame
5 years2
Number of participants with surgical complications of SSC transplantation and testicular tissue grafting
Rate of infection, hospital readmission, re-operation occurs
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov