Patients with Rotulian Tendinopathy MedDRA version: 20.0 Level: HLGT Classification code 10043237 Term: Tendon, ligament and cartilage disorders System Organ Class: 100000004859
Conditions
Interventions
Product Name: M2R. Terapia sérica autóloga con células de la serie blanca
Pharmaceutical Form: Blood fraction modifier
INN or Proposed INN: M2R. Terapia Sérica autóloga con células de la serie blanca
Sponsors
XCELL Medical Solutions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient that have willingly signed and have to be able to sign the informed consent for the participation in the trial. 2. Patients aged between 18 and 70 years, in case of woman of fertile age, the use of a contraceptive method. 3. Outpatient before the injury, without help for walk or need to assistance of other person. 4. Patients Diagnosed with unilateral lesion at the inferior pole of the patella, with echographic images of anteroposterior thickening, focal area of hypoechoic changes and discontinuity of tendon fibers. 5. Persistence of the symptoms after at least 3 months of conservative treatment. 6. Patients for whom non-surgical treatment has been decided. 7. Patient be able (in investigator´s opinion) to meet all the study requirements. 8. Patients that practice sports usually, whether they are elite athletes or amateurs. 9. Patients willing to attend the site for scheduled visits in the 24-week of follow-up. 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with lesions in both rotulian tendons 2. Severe pre-injury of tendon or ankle or deformity in any of the lower limbs. 3. Previous infiltration or previous surgery on the knee. 4. Medical History of diabetes mellitus. 5. Patients with known plasma abnormalities or haematological disorder: A. Platelet abnormality (<150,000 plat / mm3). B. Hematologic abnormality. C. Hemoglobin in blood <11g / dL or hematocrit <34% 6. Current use of systemic cortisone or treatment with anticoagulants (ie, a prophylactic dose for the prevention of thrombosis would not be an exclusion criteria) 7. Evidence of gangrene of the lower extremities / ulcers or peripheral vascular disorder. 8. History of liver failure or renal failure or dialysis 9. Female patients who are pregnant or with the intention of becoming pregnant 10. Patients that currently are receiving radiotherapy or chemotherapy or has received it in the last 3 months. 11. Patients with an inadequate venous access for blood collection. 12. Any other significant disease or disorder that, in the opinion of the investigator, could put participants at risk due to participation in the study, or may influence in the results of the study, or the ability of patients to participate in the study .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate and compare the effectiveness in pain reduction and safety in a treatment based in a therapy with serical autologous white cells versus the use of Platelet Rich Plasma with the commercial Kit of GPS® III from Biomet Biologics.;Primary end point(s): Evolution of the pain and severity of the injury: -Victorian Institute of Sports Assessment: Rotulian Tendinophaty (VISA-P) -Visual analogue Scale for pain (VAS);Timepoint(s) of evaluation of this end point: Weeks 2, 4, 8, 12 y 24;Secondary Objective: Evaluate and compare the efficacy in the recovery of mobility in a treatment based in a therapy with serical autologous cells versus the use of Platelet Rich Plasma with the commercial kit of GPS® III of Biomet Biologics. -Evaluate and compare the efficacy in the state of the injury in a treatment based in a therapy with serical autologous cells versus the use of Platelet Rich Plasma with the commercial kit of GPS® III of Biomet Biologics. -Evaluate the patients satisfaction with treatment based in a therapy with serical autologous cells versus the use of Platelet Rich Plasma with the commercial kit of GPS® III of Biomet Biologics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evolution of the injury of the tendon at functional and histological level;Timepoint(s) of evaluation of this end point: Weeks 2, 4, 8, 12 y 24 | — |
Countries
Spain
Contacts
Public ContactPablo García de la Riva
XCELL Medical Solutions SL
Outcome results
None listed