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

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ClinicalTrials.gov Identifier: NCT03454737
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Terapia Regenerativa Tissular

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


Condition or disease Intervention/treatment Phase
Patellar Tendinopathy Procedure: mesenchymal stem cells Procedure: Pure platelet-rich plasma Not Applicable

Detailed Description:
  • Main objective

    1. Confirm the presence of patellar tendon gap regeneration after the peritendinous and intratendinous infusion of MSV and compare it with the P-PRP group, evaluated by ECO, NMR and UTC.
    2. To evaluate the clinical efficacy of infusion of MSC in refractory patellar tendinopathy compared with the P-PRP group through the subjective clinical evolution of the patient, the EVA and VISA-P questionnaires and the strength of the extensor muscle group measured by dynamometry.
  • 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : December 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: mesenchymal stem cells Procedure: mesenchymal stem cells

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


Active Comparator: Pure platelet-rich plasma Procedure: Pure platelet-rich plasma

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%.





Primary Outcome Measures :
  1. Improvement in the tendon ecotexture [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Presence of patellar tendon regeneration by the peritendinous and intratendinous infusion of MSV patellar tendinopathy compared to the P-PRP group [ Time Frame: 24 months ]
    Using ECO, RMN and UTC (Ultrasound Tissue Characterisation)

  2. the strength of the extensor muscle group [ Time Frame: 24 months ]
    using dynamometry.

  3. subjective clinical evolution of the patient [ Time Frame: 24 months ]
    Using EVA and VISA-P (Victorian Institute of Sport Assessment (patelar)) questionnaries.

  4. strength of the extensor muscle group [ Time Frame: 24 months ]
    Using dynamometry



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male sex with ages between 18 and 48 years.
  2. 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.
  3. 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.
  4. MRI of the patellar tendon in T2 FAT SAT sequence (fat saturation) that shows a gap ≥3mm in longitudinal diameter in 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.

Exclusion Criteria:

  1. Patient under 18 years of age (or legally dependent) and over 48 years of age.
  2. MRI with grade III-IV intra-articular pathology of all compartments of the knee 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. Present infection (no local or systemic infectious signs should be evidenced).
  6. Patients presenting positive serology in front of:

    HIV 1 and 2, Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ab), Lúes.

  7. Congenital or evolutive diseases that translate malformation and / or significant deformations of the knee and condition difficulties of application and evaluation of the results.
  8. Weight overload expressed in body mass index (BMI) greater than 30.5 (obesity grade II). Being BMI = mass (Kg): (height (m)) 2
  9. Active neoplastic disease.
  10. Active immunosuppressive 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 criteri

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454737


Contacts
Contact: Gil Rodas, MD +34 932906042 gil.rodas@fcbarcelona.cat
Contact: Carme Barbero carme.barbero@itrt.es

Locations
Spain
Institut de Terapia Regenerativa Tissular Recruiting
Barcelona, Spain, 08022
Contact: Gil Rodas, MD    +34 932906042    gil.rodas@fcbarcelona.cat   
Contact: Carme Barbero    +34 932906042    carme.barbero@itrt.es   
Sponsors and Collaborators
Institut de Terapia Regenerativa Tissular
Investigators
Principal Investigator: Gil Rodas, MD Centro Médico Teknon

Responsible Party: Institut de Terapia Regenerativa Tissular
ClinicalTrials.gov Identifier: NCT03454737     History of Changes
Other Study ID Numbers: MSC-TENDO-2015
2016-001262-28 ( EudraCT Number )
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries