NCT04670302

Brief Summary

This is a non-randomized clinical trial conducted in a single tertiary hospital which investigates the efficacy of allogeneic adipose-derived mesenchymal stem cells and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

December 8, 2020

Last Update Submit

December 15, 2020

Conditions

Supraspinatus Tear

Keywords

Supraspinatus ruptureSupraspinatus tearTendon repairTendon tissue engineeringAmniotic membraneMesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

  • Active range of motion (AROM) pre-surgery

    Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.

    Pre-surgery

  • Active range of motion (AROM) at 12 months follow-up

    Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.

    12 months

Secondary Outcomes (7)

  • Pain pre-surgery

    Pre-surgery Outcome

  • Pain at follow-up 12 months

    12 months

  • Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery

    Pre-surgery

  • Disabilities of the Arm, Shoulder, and Hand (DASH) score at follow-up 12 months

    12 months

  • Constant-Murley Score (CS) pre-surgery

    Pre-surgery

  • +2 more secondary outcomes

Study Arms (2)

Control group (Tendon repair)

ACTIVE COMPARATOR

The control group will undergo tendon repair procedure only (without augmentation)

Procedure: Tendon repair procedure

Experimental group (Tendon repair augmented with AAdMSC-HAM composite)

EXPERIMENTAL

The experimental group will undergo tendon repair procedure augmented with AAdMSC-HAM composite

Procedure: Tendon repair augmented with AAdMSC-HAM composite

Interventions

Tendon repair procedurePROCEDURE

Tendon repair procedure: 1. Single senior surgeon (HS) will perform mini-open surgery to decompress the acromioplasty and repair the supraspinatus tendon. 2. Splicing is achieved by installing screw-type anchors on the insertional footprint of the humeral head greater tuberosity. 3. Then, double suturing of the supraspinatus tendon is performed.

Control group (Tendon repair)
Tendon repair augmented with AAdMSC-HAM compositePROCEDURE

After double suturing of the supraspinatus tendon, the composite comprising freeze-dried HAM (2 cm x 2 cm x 0.002 cm) and AAdMSC (20 million cells) is placed on the upper surface of the splice and fixed with stitches at all four corners.

Experimental group (Tendon repair augmented with AAdMSC-HAM composite)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suffering from complete/total tear of supraspinatus tendon for a duration of fewer than 12 months
  • Diagnosis is established based on clinical condition and ultrasonography or MRI examination

You may not qualify if:

  • Patients with comorbid diseases: Diabetes Mellitus, Rheumatoid Arthritis, and other inflammatory diseases.
  • Patients presenting with other related injuries, such as fractures or dislocation around the shoulder joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Soetomo General Academic Hospital/ Department Orthopaedic & Traumatology Faculty of Medicine Universitas Airlangga

Surabaya, East Java, 60286, Indonesia

RECRUITING

Study Officials

  • Heri Suroto, MD, PhD

    Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heri Suroto, MD, PhD

CONTACT

62 31 5038335hsuroto2000@yahoo.com

Heri Suroto, MD, PhD

CONTACT

62 31 5020251heri-suroto@fk.unair.ac.id

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 17, 2020

Study Start

October 17, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

ID(1)