The use of mesenchymal stem cells from the bone marrow stroma for reconstruction of the anterior cruciate ligament - MSC-ACLrep

Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center0 sites12 target enrollmentJuly 10, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center
Enrollment: 12
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

July 10, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center

•1\. Expressing informed consent to participate in the study along with participation in rehabilitation.
•2\. No contraindications to bone marrow donation.
•3\. Diagnosis of anterior knee cruciate ligament rupture not later than 6 months before qualification.
•4\. Age: 18\-45 years old.
•5\. Patient's readiness to follow the procedures related to the trial (in the opinion of the principal investigator).
•6\. For women of childbearing potential, the inclusion criterion is a negative laboratory pregnancy test and no pregnancy during study participation and subsequent imaging (e.g. use of effective contraception and a negative pregnancy test prior to imaging).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 12

•1\. Lack of consent for bone marrow collection or failure to meet the criteria for tissue donation.
•2\. Other ligament pathologies requiring surgery, confirmed by MRI and clinical examination.
•3\. A neurological or psychiatric disorder which, in the investigator's opinion, will prevent sufficient cooperation.
•4\. Failure of at least one organ (heart, liver, kidneys, lungs) with statistically predicted life expectancy \<2 years.
•5\. Condition after oncological treatment for malignant tumor (grace period of 5 years).
•6\. Participation in any other clinical trial (grace period of at least six months).
•7\. Participation in a therapeutic experiment (grace period of at least 2 years)
•8\. Allergy to gentamycin or any of the following: penicillin or streptomycin.
•9\. Systemic immunosuppressive treatment currently and / or during the last 3 years before the date of inclusion in the study (non\-biological immunosuppressive drugs may be used in doses maintaining remission provided that the exacerbation of the underlying disease is excluded).
•10\. Active infection: HIV, HBV, HCV, syphilis.