Patellar TendinopathyTENDONCT03454737
Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.
A study testing mesenchymal stem cells and Pure platelet-rich plasma in people with Patellar Tendinopathy, run by Institut de Terapia Regenerativa Tissular at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- mesenchymal stem cells and Pure platelet-rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2017to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
- Conditions
- Patellar Tendinopathy
- Being tested
- mesenchymal stem cells, Pure platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsProcedure or surgery
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 plasmaProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Not described Receives: Procedure: mesenchymal stem cells |
| Pure platelet-rich plasma | Active comparator | Not described Receives: Procedure: Pure platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Using ECO, RMN and UTC (Ultrasound Tissue Characterisation)
Measured: 24 months
the strength of the extensor muscle group
using dynamometry.
Measured: 24 months
subjective clinical evolution of the patient
Using EVA and VISA-P (Victorian Institute of Sport Assessment (patelar)) questionnaries.
Measured: 24 months
strength of the extensor muscle group
Using dynamometry
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start13 Dec 2017
- Primary completion20 Jun 2019 (estimated)
- Study completion14 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Terapia Regenerativa Tissular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil Rodas, MD, Principal investigator, Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454737
- Sponsor's protocol ID
- MSC-TENDO-2015
- Other IDs
- 2016-001262-28, 2016
- Acronym
- TENDO
- Status last verified
- Mar 2018
- First submitted
- 4 Jan 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 33783227Rodas 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Patellar Tendinopathy With Mesenquimal Trunk Cells. Comparative Study With PRP.
- ClinicalTrials.gov ID
- NCT03454737
- Acronym / sponsor ID
- TENDO / MSC-TENDO-2015
- Conditions
- Patellar Tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut de Terapia Regenerativa TissularUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 14 Dec 2020 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Procedure: mesenchymal stem cells |
| Pure platelet-rich plasma | Active comparator | Procedure: Pure platelet-rich plasma |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesenchymal stem cellsAutologous 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 | Procedure or surgery | mesenchymal stem cells |
| Pure platelet-rich plasmaUnder 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%. | Procedure or surgery | Pure platelet-rich plasma |
Primary outcome
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.
4 secondary outcomes
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
the strength of the extensor muscle group
Time frame: 24 months
subjective clinical evolution of the patient
Time frame: 24 months
strength of the extensor muscle group
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 33783227Rodas 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.
- Derived from this study: PubMed 31842921Rodas 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Rodas, MD principal investigator
Centro Médico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mesenchymal stem cells and Pure platelet-rich plasma in people with Patellar Tendinopathy, run by Institut de Terapia Regenerativa Tissular at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the tendon ecotexture (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.