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Status unknownNCT03454737TENDOUpdated Dec 19, 2018

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

An interventional study of mesenchymal stem cells and Pure platelet-rich plasma in Patellar Tendinopathy, sponsored by Institut de Terapia Regenerativa Tissular. Status unknown at 1 site in Spain. Open to male participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Institut de Terapia Regenerativa Tissular · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 48 Years
Sex
Male
01

Study 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

Read the 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
02

Conditions studied

  • Patellar Tendinopathy

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03

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    mesenchymal stem cells

    Procedure: mesenchymal stem cells

  • Active comparator
    Pure platelet-rich plasma

    Procedure: Pure platelet-rich plasma

Interventions

  • Proceduremesenchymal 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

  • ProcedurePure 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%.

05

What researchers measure

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.

    Time frame: 24 months

Secondary outcomes

  1. 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)

    Time frame: 24 months

  2. the strength of the extensor muscle group

    using dynamometry.

    Time frame: 24 months

  3. subjective clinical evolution of the patient

    Using EVA and VISA-P (Victorian Institute of Sport Assessment (patelar)) questionnaries.

    Time frame: 24 months

  4. strength of the extensor muscle group

    Using dynamometry

    Time frame: 24 months

06

Study locations

1 site
  • Institut de Terapia Regenerativa Tissular
    Barcelona, 08022, Spain
07

References and documents

Publications

  • 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. PubMed 33783227 ↗
  • 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. PubMed 31842921 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03454737
Lead sponsor
Institut de Terapia Regenerativa Tissular
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Dec 13, 2017
Primary completion
Jun 20, 2019 (estimated)
Completion
Dec 14, 2020 (estimated)
Last update
Dec 19, 2018

Study contacts

Gil Rodas, MD
principal investigator · Centro Médico Teknon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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