Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05158933
Other study ID # ATG-2-MSC-012
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 Ovarian Failure


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 Ovarian Failure. 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 Ovarian Failure - Understanding and willingness to sign a written informed consent document Exclusion Criteria: - Active infection - Active cancer - Chronic multisystem organ failure - Pregnancy - 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
Completed NCT01197456 - Predictors of Ovarian Insufficiency in Young Breast Cancer Patients
Not yet recruiting NCT03674164 - Fertility Preservation With Ovarian Tissue Freezing N/A
Not yet recruiting NCT02280681 - MAR With Artificial Gametes: Treatment Characteristics and Their Trade-offs Determining Treatment Preference N/A
Completed NCT04776902 - Effects of Ovarian Reserve on Sexual Satisfaction N/A
Recruiting NCT04275700 - Study of PRP in Women With Evidence of Diminished Ovarian Reserve N/A
Completed NCT03398603 - Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
Not yet recruiting NCT04306185 - Ovarian Fragmentation Study (Crespo Medical Team) N/A
Not yet recruiting NCT03475758 - Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide Phase 2
Not yet recruiting NCT06426771 - Effect of Antimullerian Hormone Levels on the Inflammatory Index, Phytochemical Index and NRF Nutrient Density
Enrolling by invitation NCT04009473 - Stem Cell Therapy and Growth Factor Ovarian in Vitro Activation Phase 1/Phase 2
Completed NCT03040921 - Uterine Transposition: Feasibility Study N/A
Active, not recruiting NCT04444245 - Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF Phase 1
Completed NCT06394466 - Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy
Completed NCT03907618 - Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes
Recruiting NCT05181748 - Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders Phase 2/Phase 3
Completed NCT04024449 - Can Celiac Disease Affect Ovarian Function in Adolescent?
Completed NCT04163640 - Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response N/A