Clinical Trials Logo
  1. Home
  2. Oligospermia
  3. NCT05158114
  4. Details
NCT05158114 Clinical Trial

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia

Oligospermia Clinical Trial

Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Testicular Injury and Oligospermia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05158114
Other study ID # ATG-2-MSC-013
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 2022
Est. completion date January 2026

Study information
Verified date November 2021
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations
Country Name City State
Antigua and Barbuda Medical Surgical Associates Center St. John's

Sponsors (1)
Lead Sponsor Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Country where clinical trial is conducted

Antigua and Barbuda, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (adverse events) Clinical monitoring of possible adverse events or complications Four year follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Recruiting NCT04795440 - Comparison of ICSI Outcomes in Cycles Using Testicular and Ejaculate Sperm From Couples With High SDF N/A
Completed NCT03898752 - Is Oxidative Stress in Semen Reduced by Lifestyle Intervention N/A
Recruiting NCT02063256 - 7 NUTS Study. Diet Modification and Male Fertility. Phase 2/Phase 3
Active, not recruiting NCT05134428 - Safety Evaluation of the ADAM System N/A
Not yet recruiting NCT06260007 - Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia Phase 4
Terminated NCT00440180 - Aromatase Inhibitors in the Treatment of Male Infertility Phase 3
Completed NCT01409837 - The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count Phase 2
Completed NCT01239186 - Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men N/A
Not yet recruiting NCT00479960 - A Preliminary Study on Effect of Omega-3 on Human Sperm Phase 0
Recruiting NCT06342856 - Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia Early Phase 1
Recruiting NCT01856361 - Ramipril for the Treatment of Oligospermia N/A
Recruiting NCT05842239 - Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia. N/A
Completed NCT01509482 - Insulin Resistance in Idiopathic Oligospermia and Azoospermia N/A
Not yet recruiting NCT01520584 - Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality N/A
Completed NCT00548977 - Genetic Studies Spermatogenic Failure N/A
Completed NCT04349345 - Seminal Fluid's Changes Over 20 Years
Recruiting NCT05320536 - A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia Phase 4
Completed NCT02234206 - A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count Phase 2
Recruiting NCT06202469 - Creatine and Ubiquinol for Sperm Quality N/A