Rupture of the anterior cruciate ligament in the knee MedDRA version: 20.0 Level: PT Classification code 10049548 Term: Knee operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Bone-marrow derived autologous stem cells
Product Code: MSC ATiMP
Pharmaceutical Form: Suspension for injection
Sponsors
Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 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 600,000 platelets. 14. General diseases, including diabetes, gout, especially those requiring chronic intake of oral steroids, in intravenous or topical injections. 15. Osteoarthritis. 16. Past infections in the knee. 17. Condition after lateral or medial meniscectomy 18. Disorder of the mechanical axis of the lower limb> 3 degrees. 19. Previous cartilage repair procedures or ligament reconstruction. 20. Diseases or injuries of the musculoskeletal system impeding efficient mobility. 21. Cardiovascular or neurological diseases affecting the condition of the lower extremities. 22. BMI> 27 23. Smoking cigarettes, pipes, cigars. 24. Alcohol dependence syndrome. 25. Use of drugs and / or other intoxicants. 26. Contraindications to perform an MRI examination, including all implants for which the patient does not have documentation to determine compatibility with the MRI examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Visits: 2, 3, 4, 5, 6, ;Main Objective: The aim of the study is to assess the intra-ligamental safety of administration of an advanced therapy medicinal product - autologous mesenchymal stem cells isolated from bone marrow (MSC ATiMP) in the treatment of anterior cruciate ligament in the knee.;Secondary Objective: A secondary goal is the preliminary assessment of the efficacy of intrathecal (intramiginal) administration of MSC ATiMP in the treatment of anterior cruciate ligament ruptures.;Primary end point(s): Safety assessment: Type and frequency of adverse reactions and events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Initial effectiveness assessment: Scoring in functional scales (KOOS, Lysholm) and in imaging tests (MRI, ultrasound);Timepoint(s) of evaluation of this end point: Visits: 2, 3, 4, 5, 6, | — |
Countries
Poland
Contacts
Public ContactMikolaj Wróbel
Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center
Outcome results
None listed