Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Testicular Injury and Oligospermia
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Safety (adverse events)
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Testicular Injury or Oligospermia
- •Understanding and willingness to sign a written informed consent document
Exclusion Criteria
- •Active infection
- •Active cancer
- •Chronic multisystem organ failure
- •Clinically significant Abnormalities on pre-treatment laboratory evaluation
- •Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- •Continued drug abuse
- •Previous organ transplant
- •Hypersensitivity to sulfur
Arms & Interventions
Treatment Group (AlloRx)
Single intravenous infusion of 100 million cells
Intervention: AlloRx (Biological)
Outcomes
Primary Outcomes
Safety (adverse events)
Time Frame: Four year follow-up
Clinical monitoring of possible adverse events or complications
Secondary Outcomes
No secondary outcomes reported