Patients diagnosed with patellar tendinopathy with a minimum of 4 months evolution and have presented two acute episodes, refractory to standard treatments present a gap equal or greater than 3 mm at rest. MedDRA version: 20.0 Level: LLT Classification code 10034123 Term: Patellar tendinitis System Organ Class: 100000004859
Conditions
Interventions
Product Name: MSV -células progenitoras mesenquimales de médula ósea autóloga expandidas con procedimientos NCF
Pharmaceutical Form: Living tissue equivalent
INN or Proposed INN: MSV-CMT
Other descrip
Sponsors
Institut de Terapia Regenerativa Tissular S.L. (ITRT)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males with ages between 18 and 48 years. 2. Patellar tendon pain, located in the insertion zone, of more than 4 months duration that does not show significant improvement after conservative treatments such as rest, analgesia, physiotherapy and / or infiltration. 3. Echographic image confirming, in both static and dynamic states, the loss of the fibrillar structure of the proximal part of the patellar tendon, thickening of the patellar tendon and a hypoechogenic lesion compatible with a gap =3 mm. 4. Patellar tendon MRI scan T2 FAT SAT (fat saturation) showing a gap =3mm in longitudinal diameter at the proximal insertion. 5. Informed Consent in writing and signed by the patient. 6. The patient is able to understand the nature of the study 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient under 18 years of age (or legally dependent) and over 48 years. 2. MRI with grade III-IV intrarticular pathology of all knee compartments and / or cruciate ligament injury 3. Local treatment with corticosteroids during the last year 4. Local treatment with PRP during the last 6 months. 5. Infection (no local or systemic infectious signs should be evident). 6. Patients presenting positive serology against: HIV 1 and 2, Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ab), Syphilis. 7. Congenital or evolutional diseases that cause malformation and / or significant deformation of the knee and condition difficulties of application and evaluation of the results. 8. Overweight expressed in body mass index (BMI) greater than 30.5 (obesity grade II). If BMI = mass (Kg): (height (m)) 2 9. Active neoplastic disease. 10. Active immunodepressive states. 11. Simultaneous participation in another clinical trial or treatment with another product in the research phase in the 30 days prior to inclusion in the study. 12. Other pathologies or circumstances that compromise participation in the study according to medical criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Confirm the presence of regeneration of the patellar tendon gap after peritendinous and intratendinous infusion of MSV and the comparison with the P-PRP group evaluated with ultrasound, MRI and UTC. -To assess the clinical efficacy of MSV infusion by means of refractory patellar tendinopathy compared to the P-PRP group by subjective patient outcomes, VAS and VISA-P questionnaires and the strength of the extensor muscle group using dynamometry.;Secondary Objective: To assess the viability and safety of the advanced therapy medicinal product MSV and P-PRP when applied by percutaneous infusion into the patellar tendon, demonstrating that each of the procedures established in the protocol is feasible and registering the possible related adverse effects With both treatments and adverse events occurring during the clinical trial period, whether or not they are related to them.;Primary end point(s): The objective is to evaluate the response by: 1. Ultrasound: The patellar tendon will be examined longitudinally and transversely using gray scale and color, exerting a minimal pressure with the probe. Images will be recorded in static and dynamic formats to build a consensus of the findings. The therapeutic action will be considered positive if there is evidence of improvement of the tendon ecotexture, reduction of the gap, reduction of neovascularization and, to a lesser extent, decrease in thickness, since this latter parameter is conditioned by the adaptive-protective effect of the Increase in thickness; Ie both increase and decrease may represent a favorable aspect (Warden 2007). It will be determined: 1. Location of the lesion (medial, central, lateral) and (anterior, central, posterior). 2. Thickness of the tendon at 5 mm from the inferior pole of the kneecap. 3. Ecotexture using scale 0-3. 4. GAP longitudinal, axial measures and area value. 5. Vascularization degree I-V 2.- UTC: The tendon eco-architecture will be evaluated by establishing 4 subtypes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.- Pain and Functionality: The evolution of the classic visual analog scale (VAS) will be recorded, taking as reference the baseline value established before the treatment and by means of manual dynamometer (HHD) will measure the forces of extension of the knee. The somewhat functional evaluation will be performed using the VISA-P score, specific to evaluate pain and functionality in patellar tendinopathy. It is a scale from 0 to 100. The value 100 would indicate absence of pain at rest, walking, going down or up stairs or during exercise (Hernández-Sanchez 2012). Usually patients with chronic patellar tendinopathy have values ??between 30 to 50, from 60 is allowed to start physical activity and with values ??above 70 is fit for competition, although in professional sports the demands are greater. The minimum significant difference has been set at 13 points. Criteria for the assessment of improvement applied in this trial (Hoksrud 2011): - Desired: = 60/100 (at 3 months) - Very satisfactory: = 70/100 (at 6 months) - Ideal: = 80/100 (at 12 months) 2.- Adverse Effects: Possible adverse events, related or not related with the procedure, that can occur throughout the test, will be recorded and tabulated. 3.- Concomitant medication: The concomitant medication will be registered from the day of application of treatment, until the termination of the study.;Timepoint(s) of evaluation of this end point: 12 Months | — |
Countries
Spain
Contacts
Public ContactProject Coordinator
Institut de Terapia Regenerativa Tissular S.L. (ITRT)
Outcome results
None listed