Status:
WITHDRAWN
Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)
Lead Sponsor:
Human Brain Wave S.r.l.
Collaborating Sponsors:
Nextrasearch S.r.l.s.
Ibismed S.r.l.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare in 60 patients suffering for Knee OA to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compar...
Detailed Description
All the patients participating in the study will have had been diagnosed with degenerative knee chondropathy from grade II to III of Kellgren-Lawrence grading scale and they will have signed a consent...
Eligibility Criteria
Inclusion
- Male or female age 25-65 inclusive with open physis confirmed by MRI (Size of the articular cartilage lesion is ≥ 2 cm2)
- Documented symptomatic stable diagnosed degenerative knee chondropathy from grade II to III based on MRI without changes of osteoarthritis and no prior history of knee surgery. The MRI diagnosis must be within a 3-month time period prior to consent.
- Joint pain: 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
- The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
- Body Mass Index (BMI) ≤ 30 kg/m2 (extremely obese)
- No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
- Patient has complied with the requirements for rescue medication (no more than 4 tablets or 2 grams of paracetamol per day up to 4 days per week
- Patients will have signed a consent informed
Exclusion
- Patients with polyarticular disease (not applicable to polyarticular disease of the knees as the most symptomatic knee will qualify for the study)
- Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL).
- Patients who had intra-articular treatment with steroids within 3 months
- Patients who are pregnant or nursing at the time of consent.
- Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
- Patients who had previous knee surgery
- Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
- Chronic use of NSAID (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs
- Treatment with NSAIDs within 15 days prior to randomization in this study
- Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects.
- Patients with acute or chronic renal failure
- Patients who received a MRI diagnosis of OCD but do not have the specific cartilage imaging sequences.
- Clinical or laboratory evidence of septicemia
- Any problems in the ear tissue affecting the collection of cartilage
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06123689
Start Date
March 1 2024
End Date
May 15 2024
Last Update
July 3 2025
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