NCT03688308

Brief Summary

The primary objective is to determine whether adjunct treatment using bone marrow aspirate concentrate (BMAC) in conjunction with arthroscopic repair of rotator cuff tears reduces retear rates compared to a control population undergoing arthroscopic repair without BMAC administration. The secondary objectives are to (1) evaluate the survival and incorporation of BMAC labeled cells with MRI imaging using the Ferumoxytol infusion stem cell labeling technique, and (2) determine if administration of BMAC leads to better clinical outcomes as measured by ASES, UCLA and Constant scoring metrics.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

September 21, 2018

Last Update Submit

April 21, 2021

Conditions

Rotator Cuff TearRotator Cuff Injury

Keywords

Bone marrow aspirateBiologics

Outcome Measures

Primary Outcomes (1)

  • Tendon healing rates

    Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery

    24 months

Secondary Outcomes (4)

  • UCLA Score

    Date of enrollment to 24 months post-operatively

  • ASES Score

    Date of enrollment to 24 months post-operatively

  • Constant Score

    Date of enrollment to 24 months post-operatively

  • Retention of the mesenchymal stem cells

    7 days

Study Arms (2)

Shoulder arthroscopy with BMAC

EXPERIMENTAL

This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair along with 3-4cc of BMAC produced from the Harvest/Terumo BCT system

Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate

Shoulder arthroscopy alone

ACTIVE COMPARATOR

This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair without administration of BMAC.

Procedure: Arthroscopic rotator cuff repair

Interventions

Arthroscopic rotator cuff repair with bone marrow aspirate concentratePROCEDURE

Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique. Subjects will also be injected with bone marrow aspirate concentrate harvested from the pelvis and centrifuged prior to injection in the shoulder (produced using the Harvest/Terumo BCT system)

Also known as: Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)
Shoulder arthroscopy with BMAC
Arthroscopic rotator cuff repairPROCEDURE

Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.

Shoulder arthroscopy alone

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 50-75 patients with MRI confirmed rotator cuff tears sized 1.5-3cm including supraspinatus with or without an associated partial infraspinatus or subscapularis tear
  • Chronic tear \> 3 months
  • Failed a minimum of 6 weeks of physical therapy
  • Hamada stage 1
  • Goutallier staging \< 3

You may not qualify if:

  • Radiographs demonstrating mild to moderate arthritis
  • Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
  • Hamada stage \> 2
  • Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
  • Brachial plexus pathology
  • Currently pregnant or planning to become pregnant
  • Shoulder PRP injection within the last year
  • History of iron overload syndrome
  • Concurrent surgery for shoulder instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Jason L Dragoo

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients will not know if they received the surgical intervention that includes BMAC administration
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 28, 2018

Study Start

January 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)