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The Effectiveness of Adding Allogenic Stem Cells After Traditional Treatment of Osteochondral Lesions of the Talus (OLT)

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ClinicalTrials.gov Identifier: NCT03905824
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Manuel J Pellegrini, University of Chile

Brief Summary:

Randomized, multicentric, prospective, double-blind study: effectiveness of adding allogenic stem cells to a platelet-poor plasma scaffold after arthroscopic debridement and microfractures in patients with osteochondral lesions of the talus Osteochondral lesions of the talus (LOC), affects the ankle cartilage, which it seems to have less repair capacity than that of other joints such as the knee of the hip. The LOC can be an important source of pain and affects comparatively younger, working age and athletically active patients.

Although there are several therapeutic strategies, debridement and microfractures performed arthroscopically are the most frequent procedures. After this surgery, it is expected that fibrocartilage will form that covers the osteochondral lesion. Though good results have been reported, this fibrocartilage presents histological characteristics of lower quality to those of the native articular cartilage.

Based on previous studies in different joints, it is hypothesized that the augmentation treatment of osteochondral lesions of the talus with mesenchymal allogeneic stromal cells derived from the umbilical cord produces better clinical and imaging results than standard treatment with debridement and microfractures only.

Therefore, the present study seeks to compare the effectiveness of traditional debridement and microfracture treatment versus adding a platelet-poor plasma (PPP) scaffold embedded in allogeneic mesenchymal stromal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.


Condition or disease Intervention/treatment Phase
Osteochondral Fracture of Talus Biological: Allogenic stromal mesenchymal cells derived from the umbilical cord Procedure: Debridement and microfracture Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Multicentric, Prospective, Double-blind Study: Effectiveness of Adding Allogenic Stem Cells to a Platelet-poor Plasma Scaffold After Arthroscopic Debridement and Microfractures in Patients With Osteochondral Lesions of the Talus
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Debridement and microfracture in LOC + Cells
Traditional debridement and microfracture treatment adding a platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord in patients with osteochondral lesions of the talus.
Biological: Allogenic stromal mesenchymal cells derived from the umbilical cord
Platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord added to the traditional treatment for osteochondral lesions of the talus

Procedure: Debridement and microfracture
Debridement and microfracture in LOC is the traditional treatment for osteochondral lesions of the talus

Active Comparator: Debridement and microfracture in LOC
Traditional debridement and microfracture treatment in patients with osteochondral lesions of the talus.
Procedure: Debridement and microfracture
Debridement and microfracture in LOC is the traditional treatment for osteochondral lesions of the talus




Primary Outcome Measures :
  1. Change on tissue reparation quality [ Time Frame: Baseline and 1 year follow up ]
    Magnetic resonance observation of cartilage repair tissue (MOCART). The MOCART classification is one of the most frequently used MR score for postoperative cartilage repair tissue evaluation. The MOCART score is a 9-part and 29-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.

  2. Change over time of general health status [ Time Frame: Baseline, 1 year and 2 years follow up ]

    The MOS SF-36, It is a generic scale to evaluate health/disease status. It comprises 36 items divided into two components: Physical Health (PH) and Mental Health (MH). PH includes four subscales: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), and General Health (GH). MH includes four subscales: Vitality (V), Social functioning (SF), Role Emotional (RE), and General Health (GH).

    Each component (PH and MH) and each of the eight subscale scores are transformed into a 0-to-100 scale. Higher scores represent better health status


  3. Change over time of functional limitations of foot and ankle. [ Time Frame: Baseline, 1 year and 2 years follow up ]

    The Foot and Ankle Outcome Score (FAOS) evaluates functional limitations related to foot and ankle issues. Consist in 42 items that cover 5 dimensions: Symptoms (S: 7 items), Pain (P: 9 items), Activities of Daily Living (ADL: 17 items), Sport and Recreation Activities (SRA: 5 items), and foot and ankle related Quality of Life (QoL: 4 items). Raw scores of each sub-scales results of the sum of each item score.

    These raw scores are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition.


  4. Change over time of functionality of musculoskeletal ankle and foot pathology [ Time Frame: Baseline, 1 year and 2 years follow up ]

    The Foot and Ankle Ability Measure (FAAM) scale aims to evaluate overtime changes in the functionality of the same patient in musculoskeletal ankle and foot pathology. It is a survey that consists of 21 items about activities of daily living, and 8 items about sports skills.

    Raw scores of each sub-scales are standardised into a 0 to 100 scale; higher scores mean higher dysfunction due to foot/ankle condition.


  5. Change on declared pain [ Time Frame: Baseline, 1 year and 2 years follow up ]

    Visual Analog Scale for Pain (VAS-Pain): a pain rating scale based on self-reported measures of symptoms. A 10cm line numbered from 0 to 10 represents a continuum between "no pain" (zero) and "worst pain" (ten).

    It can also be interpreted as a 0-to-100 points score.



Secondary Outcome Measures :
  1. Surgical time [ Time Frame: During surgery ]
    Duration (in minutes) of the surgery

  2. Complication rate [ Time Frame: Two years follow up from baseline (surgery) ]

    Including the number of participants with:

    • post-surgery infections
    • temporal or permanent damage of nerve as a result of pressure or hematoma
    • with venose thrombosis, pulmonary embolism or heart stroke

  3. Cost-effective comparative analysis [ Time Frame: Two years follow up from baseline (surgery) ]
    Comparison of the overall costs and results of both groups



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a symptomatic osteochondral lesion of the Talus.
  • Magnetic resonance of the ankle showing osteochondral injury of a single talus, with perilesional oedema

Exclusion Criteria:

  • Recurrent osteochondral lesions of the talus
  • Multiple osteochondral lesions
  • Severe ankle instability, requiring open repair
  • History of a previous foot or ankle surgery of the ipsilateral foot
  • Rheumatoid arthritis
  • Inability to return to the surgery site to practice long-term follow-up evaluations or lack of readiness to complete the indicated evaluation forms.
  • Patients with a qualitative or quantitative commitment that prevents consent or assent their participation in the study.

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): NCT03905824


Contacts
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Contact: Manuel Pellegrini, DM +56997795613 mpellegrini@hcuch.cl
Contact: Aaron Cortes, PhD +56942255914 aacortes@hcuch.cl

Locations
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Chile
Universidad de Chile Clinical Hospital Recruiting
Santiago, Independencia, Chile, 8380456
Contact: Aaron Cortes, PhD    +56942255914    aacortes@hcuch.cl   
Principal Investigator: Manuel Pellegrini, MD         
Sub-Investigator: Aaron Cortes, PdH         
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Manuel Pellegrini, MD Universidad de Chile Clinical Hospital
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Responsible Party: Manuel J Pellegrini, Principal Investigator, University of Chile
ClinicalTrials.gov Identifier: NCT03905824    
Other Study ID Numbers: OLT Protocol
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No