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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001262-28 | EudraCT Number |
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This is a clinical trial, unicentric, prospective, controlled, randomized, double blind during the experimental phase A.
In the experimental phase B, it is contemplated to administer the experimental treatment to the subjects included in the group treated with P-PRP in the event that the first treatment would be significantly more effective, both from a clinical and regenerative point of view
Main objective
Secondary objective 1. To evaluate the feasibility and safety of the advanced therapy medication MSV and P-PRP when applied by percutaneous infusion into the body of the patellar tendinosis, verifying that each of the procedures established in the protocol is feasible and recording the possible adverse effects related with both treatments and adverse events arising during the period of the clinical trial, whether or not related to it
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cells | Experimental |
| |
| Pure platelet-rich plasma | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Procedure | Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the tendon ecotexture | The patellar tendon will be examined longitudinally and transversely using gray scale and color, exerting a minimum pressure with the probe. Images will be recorded in static and dynamic formats to develop a consensus of the findings. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of patellar tendon regeneration by the peritendinous and intratendinous infusion of MSV patellar tendinopathy compared to the P-PRP group | Using ECO, RMN and UTC (Ultrasound Tissue Characterisation) | 24 months |
| the strength of the extensor muscle group |
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Inclusion Criteria:
Exclusion Criteria:
Patient under 18 years of age (or legally dependent) and over 48 years of age.
MRI with grade III-IV intra-articular pathology of all compartments of the knee and / or cruciate ligament injury
Local treatment with corticosteroids during the last year
Local treatment with PRP during the last 6 months.
Present infection (no local or systemic infectious signs should be evidenced).
Patients presenting positive serology in front of:
HIV 1 and 2, Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ab), Lúes.
Congenital or evolutive diseases that translate malformation and / or significant deformations of the knee and condition difficulties of application and evaluation of the results.
Weight overload expressed in body mass index (BMI) greater than 30.5 (obesity grade II). Being BMI = mass (Kg): (height (m)) 2
Active neoplastic disease.
Active immunosuppressive states.
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.
Other pathologies or circumstances that compromise participation in the study according to medical criteri
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| Name | Affiliation | Role |
|---|---|---|
| Gil Rodas, MD | Centro Médico Teknon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Terapia Regenerativa Tissular | Barcelona | 08022 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33783227 | Derived | Rodas G, Soler-Rich R, Rius-Tarruella J, Alomar X, Balius R, Orozco L, Masci L, Maffulli N. Effect of Autologous Expanded Bone Marrow Mesenchymal Stem Cells or Leukocyte-Poor Platelet-Rich Plasma in Chronic Patellar Tendinopathy (With Gap >3 mm): Preliminary Outcomes After 6 Months of a Double-Blind, Randomized, Prospective Study. Am J Sports Med. 2021 May;49(6):1492-1504. doi: 10.1177/0363546521998725. Epub 2021 Mar 30. | |
| 31842921 |
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| Pure platelet-rich plasma | Procedure | Under aseptic conditions, in surgical medium, 6 ml of P-PRP will be obtained from 36 ml of autologous peripheral venous blood sample. The plasma coagulation will be activated by the addition of Cl2Ca at a concentration of 5%. |
|
using dynamometry. |
| 24 months |
| subjective clinical evolution of the patient | Using EVA and VISA-P (Victorian Institute of Sport Assessment (patelar)) questionnaries. | 24 months |
| strength of the extensor muscle group | Using dynamometry | 24 months |
| Derived |
| Rodas G, Soler R, Balius R, Alomar X, Peirau X, Alberca M, Sanchez A, Sancho JG, Rodellar C, Romero A, Masci L, Orozco L, Maffulli N. Autologous bone marrow expanded mesenchymal stem cells in patellar tendinopathy: protocol for a phase I/II, single-centre, randomized with active control PRP, double-blinded clinical trial. J Orthop Surg Res. 2019 Dec 16;14(1):441. doi: 10.1186/s13018-019-1477-2. |