Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.

NCT03454737 | Unknown

• 2 other identifiers: MSC-TENDO-20152016-001262-28
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patellar Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Presence of patellar tendon regeneration by the peritendinous and intratendinous infusion of MSV patellar tendinopathy compared to the P-PRP group

  24 months

• the strength of the extensor muscle group

  24 months

• subjective clinical evolution of the patient

  24 months

• strength of the extensor muscle group

  24 months

Study Arms (2)

mesenchymal stem cells

EXPERIMENTAL

Procedure: mesenchymal stem cells

Pure platelet-rich plasma

ACTIVE COMPARATOR

Procedure: Pure platelet-rich plasma

Interventions

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

mesenchymal stem cells

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%.

Pure platelet-rich plasma

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex with ages between 18 and 48 years.
• Pain in the patellar tendon, located in the patellar insertion area, of more than 4 months of duration that does not show significant improvement after conservative treatments such as rest, analgesia, physiotherapy and / or infiltration.
• Ultrasound image that confirms, both static and dynamic, the loss of the fibrillar structure of the proximal part of the patellar tendon, its thickening and a hypoechoic lesion compatible with gap ≥3mm.
• MRI of the patellar tendon in T2 FAT SAT sequence (fat saturation) that shows a gap ≥3mm in longitudinal diameter in the proximal insertion.
• Informed Consent in writing and signed by the patient.
• The patient is able to understand the nature of the study.

You may not qualify if:

• 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.
• Other pathologies or circumstances that compromise participation in the study according to medical criteri

Sponsors & Collaborators

• Institut de Terapia Regenerativa Tissular: lead

Study Sites (1)

Institut de Terapia Regenerativa Tissular

Barcelona, 08022, Spain

Location

Related Publications (2)

• 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.

  PMID: 33783227 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.

  PMID: 31842921 DERIVED

Study Officials

• Gil Rodas, MD

  Centro Médico Teknon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: March 6, 2018
• Study Start: December 13, 2017
• Primary Completion: June 20, 2019
• Study Completion: December 14, 2020
• Last Updated: December 19, 2018

Record last verified: 2018-03

Locations

ES (1)