Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05447767
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18-75;
2. Patients affected by knee OA KL 2-3;
3. Patients understanding the nature of the study and providing their informed consent to participation;
4. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
5. Body mass index (BMI) ≤ 40 kg/m2;
6. Ability to provide written informed consent and can understand and comply with the requirements of the study.
Exclusion Criteria:
A 4-arms randomized clinical trial in 240 patients affected by knee OA KL 2-3. Treatment groups: 1) intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of adipose tissue enriched in SVF (at-SVF) , 4) intraosseous and intra-articular injection of at-SVF.
Inclusion criteria:
1. Patients aged 18-75;
2. Patients affected by knee OA KL 2-3;
3. Patients understanding the nature of the study and providing their informed consent to participation;
4. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
5. Body mass index (BMI) ≤ 40 kg/m2;
6. Ability to provide written informed consent and can understand and comply with the requirements of the study.
Exclusion criteria:
1. Patients with known inflammatory diseases at the time of enrolment.
2. Patients who are not allowed to undergo the study procedures involving imaging (X-rays, MRI) based on Investigator's judgement.
3. A history of local anaesthetic and anticoagulant drug allergy;
4. Clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee;
5. Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening;
6. Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening;
7. Patients who received intra-articular injection of corticosteroids, PRP or HA within the previous 3 months;
8. Use of systemic immunosuppressants within 6 weeks prior to screening;
9. Patients with a history of invasive malignancies (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years;
10. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
11. Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for three months later.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05447767
Study Brief:
Protocol Section:
NCT05447767