A Phase 1 interventional study of AlloRx in Testicular Injury and Oligospermia, sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Withdrawn at 1 site in Antigua and Barbuda. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by The Foundation for Orthopaedics and Regenerative Medicine · Phase 1, Interventional, and Treatment
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Testicular Injury and Oligospermia
This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Testicular Injury and Oligospermia. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
Browse Oligospermia studies →The Foundation for Orthopaedics and Regenerative Medicine is the lead sponsor of 33 studies on the registry; 20 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single intravenous infusion of 100 million cells
Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Time frame: Four year follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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The Foundation for Orthopaedics and Regenerative Medicine