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

Primary Purpose

Patellar Tendinopathy

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

mesenchymal stem cells

Pure platelet-rich plasma

About this trial

This is an interventional treatment trial for Patellar Tendinopathy

Eligibility Criteria

18 Years - 48 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

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

Sites / Locations

Institut de Terapia Regenerativa Tissular

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mesenchymal stem cells

Pure platelet-rich plasma

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

the strength of the extensor muscle group

using dynamometry.

subjective clinical evolution of the patient

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

strength of the extensor muscle group

Using dynamometry

Full Information

NCT ID

NCT03454737

First Posted

January 4, 2018

Last Updated

December 18, 2018

Sponsor

Institut de Terapia Regenerativa Tissular

1. Study Identification

Unique Protocol Identification Number

NCT03454737

Brief Title

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

Acronym

TENDO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 13, 2017 (Actual)

Primary Completion Date

June 20, 2019 (Anticipated)

Study Completion Date

December 14, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Terapia Regenerativa Tissular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed Description

Main objective 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patellar Tendinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mesenchymal stem cells

Arm Type

Experimental

Arm Title

Pure platelet-rich plasma

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

mesenchymal stem cells

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Pure platelet-rich plasma

Intervention Description

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 Measure Information:

Title

Improvement in the tendon ecotexture

Description

Time Frame

24 months

Secondary Outcome Measure Information:

Title

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

Description

Using ECO, RMN and UTC (Ultrasound Tissue Characterisation)

Time Frame

24 months

Title

the strength of the extensor muscle group

Description

using dynamometry.

Time Frame

24 months

Title

subjective clinical evolution of the patient

Description

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

Time Frame

24 months

Title

strength of the extensor muscle group

Description

Using dynamometry

Time Frame

24 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gil Rodas, MD

Organizational Affiliation

Centro Médico Teknon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Terapia Regenerativa Tissular

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33783227

Citation

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.

Results Reference

derived

PubMed Identifier

31842921

Citation

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.

Results Reference

derived

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

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