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

Phase 1

• Conditions: Rupture of the anterior cruciate ligament in the knee; MedDRA version: 20.0Level: PTClassification code 10049548Term: Knee operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-002732-75-PL
• Lead Sponsor: Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-10
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

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

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.
11. Pregnancy.
12. Co-occurrence of another disease at the same time, which in the investigator's opinion may affect the course of the procedures used or the assessment of the safety and effectiveness of the treatment used.
13. Irregularities in biochemical tests
- hemoglobin <8 g / dl,
- Platelet count <80,000 or> 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified