Treatment of Refractory Patellar Tendinopathy with MSV. Comparative study with P-PRP

Phase 1

Conditions: 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: 20.0Level: LLTClassification code 10034123Term: Patellar tendinitisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2016-001262-28-ES

Lead Sponsor: Institut de Terapia Regenerativa Tissular S.L. (ITRT)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

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

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