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Trial record 45 of 6377 for:    stem cells

Clinical Study on Mesenchymal Stem Cells Used in the Reconstruction Surgery of the Supraspinatus Muscle Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03068988
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The prospective randomized clinical study investigating the effect of mesenchymal stem cells on tendon healing. The objective of the study is to demonstrate the effect of concentrated bone marrow stem cells ( MSCs ) to the healing of sutured tendon of the supraspinatus muscle in comparison to the same procedure performed without MSCs. We have postulated the hypothesis that MSCs enhance the healing of the sutured supraspinatus tendon to its humeral footprint.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Biological: mesenchymal stem cells Procedure: without mesenchymal stem cells Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells in the Reconstruction Surgery of the Supraspinatus Muscle Lesions
Actual Study Start Date : January 1, 2012
Primary Completion Date : December 31, 2014
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: mesenchymal stem cells
mesenchymal stem cells concentrate into the supraspinatus footprint during the surgery
Biological: mesenchymal stem cells
mesenchymal stem cells concentrate into the supraspinatus footprint during the surgery
Placebo Comparator: without mesenchymal stem cells
rotator cuff surgery without mesenchymal stem cells
Procedure: without mesenchymal stem cells
rotator cuff surgery without mesenchymal stem cells


Outcome Measures

Primary Outcome Measures :
  1. The supraspinatus tendon re-rupture rate [ Time Frame: 2 years postoperatively ]
    presence of the supraspinatus tendon rupture on magnetic resonance imaging evaluated 2 years after the surgery, incidence of rerupture compared between group I- with the use of mesenchymal stem cells and group II- without the use of mesenchymal stem cells


Secondary Outcome Measures :
  1. visual analogue scale [ Time Frame: 1 day before the surgery, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively, 10 years postoperatively ]
    patients subjectively rate the pain level at 6 grade scale from 0-5 where 0 represents no pain and 5 excruciating pain

  2. ASES score- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form [ Time Frame: 1 day before the surgery, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively, 10 years postoperatively ]
    Consists of two parts. The first part features a questionnaire filled in by the patients themselves, and included a visual analogue scale for pain and instability and assessment of ability to perform activities of daily living ( ADL ). The second part, which is completed by a doctor, represents an objective assessment of the conditions, and includes the evaluation of range of motion, specific physical characteristics, strength and stability. Score for the arm was then derived from the visual analogue scale for pain (50%) and the general score for ADL (50%).

  3. Constant score [ Time Frame: 1 day before the surgery, 6 months postoperatively, 1 year postoperatively, 2 years postoperatively, 5 years postoperatively, 10 years postoperatively ]
    Two parts: first- subjective evaluation of ADL ( activities of daily living ) from the patient's perspective, the second part is an objective assessment of range of motion and muscle strength performed by the physician


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women aged 18-60 years
  • chronic supraspinatus tendon tear greater than 50% of its width
  • no history of trauma to the examined shoulder girdle
  • confirmation by the clinical examination and preoperative imaging examination ( MRI arthrography )
  • signed informed consent
  • minimum preoperative haemoglobin concentration in men 13.8 g / dl, in women 12.1 g / dl

Exclusion Criteria:

  • previous surgical treatment of the rotator cuff
  • cuff tear arthropathy grade 3-5 according to Hamada
  • fatty degeneration of the cuff muscle ( Goutallier 3 and 4 )
  • atrophy of the supraspinatus muscle according to the Thomazeau classification grade II and III
  • retraction of the supraspinatus muscle tendon Patte III
  • pregnancy
  • active infection at the surgical site or elsewhere in the body
  • osteomyelitis
  • sepsis
  • history of diabetes
  • steroids use
  • chemotherapy
  • use of NSAIDs
  • radiation
  • hepatitis
  • HIV
  • hemato / oncological diseases
  • alcohol abuse
  • drug abuse
  • cigarettes
  • medical condition that affects the growth of bone or connective tissue (osteomalacia or other metabolic bone disease)
  • vascular insufficiency
  • operated extremity muscle atrophy
  • neuromuscular disease
Contacts and Locations

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): NCT03068988


Locations
Czechia
Petr Šmíd
Znojmo, Czech Republic, Czechia, 66902
Sponsors and Collaborators
Hospital Znojmo
Investigators
Principal Investigator: Petr Šmíd, Dr. General Hospital Znojmo, Czech Republic
More Information

Publications:
Responsible Party: MUDr. Petr Šmíd, Prinicpal investigator, Doctor, Hospital Znojmo
ClinicalTrials.gov Identifier: NCT03068988     History of Changes
Other Study ID Numbers: 2016/05/25/09
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by MUDr. Petr Šmíd, Hospital Znojmo:
bone marrow stem cells
rotator cuff lesion

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries