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

Patellar Tendinopathy Clinical Trial

— TENDO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03454737
• Other study ID #: MSC-TENDO-2015
• Secondary ID: 2016-001262-28
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 13, 2017
• Est. completion date: December 14, 2020

Study information

• Verified date: March 2018
• Source: Institut de Terapia Regenerativa Tissular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 14, 2020
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellar Tendinopathy
• Tendinopathy

Intervention

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
• 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%.

Locations

Country	Name	City	State
Spain	Institut de Terapia Regenerativa Tissular	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Terapia Regenerativa Tissular

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	the strength of the extensor muscle group	using dynamometry.	24 months
Secondary	subjective clinical evolution of the patient	Using EVA and VISA-P (Victorian Institute of Sport Assessment (patelar)) questionnaries.	24 months
Secondary	strength of the extensor muscle group	Using dynamometry	24 months