NCT02033525

Brief Summary

The present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (XCEL-M-ALPHA) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. For this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . The conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

January 31, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

January 8, 2014

Last Update Submit

January 8, 2018

Conditions

Chronic Meniscal Injury

Keywords

Chronic Meniscal InjuryDegenerative meniscusMeniscus injuryMeniscal injuryMesenchymal stromal cellsMesenchymal stem cellsAdvanced TherapyBone marrow

Outcome Measures

Primary Outcomes (1)

  • VAS for pain

    Visual analogue scale (VAS) for pain at 12 month follow-up.

    12 month

Secondary Outcomes (4)

  • Safety

    12 month

  • Efficacy by MRI

    6 and 12 month

  • VAS for pain

    1, 3 and 6 month

  • Efficacy by clinical questionnaires

    3, 6 and 12 month

Study Arms (2)

XCEL-M-ALPHA and standard rehabilitation

EXPERIMENTAL

Intraarticular administration of XCEL-M-ALPHA followed by standard rehabilitation program

Drug: XCEL-M-ALPHA and standard rehabilitation

standard rehabilitation

ACTIVE COMPARATOR

Standard rehabilitation program

Other: Rehabilitation

Interventions

XCEL-M-ALPHA and standard rehabilitationDRUG

Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)

Also known as: XCEL-M-ALPHA
XCEL-M-ALPHA and standard rehabilitation
RehabilitationOTHER

Standard rehabilitation program

standard rehabilitation

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient between 40 and 60 years of age
  • Degenerative meniscus injury grade 3 (Crues et al.)
  • Indication of conservative treatment
  • Normal alignment of the knee (between 3º varus and 10 º valgus)
  • Patient is able to follow a rehabilitation program
  • Informed consent given by the patient in writing
  • Patient is able to understand the trial.

You may not qualify if:

  • Traumatic meniscus injury
  • Surgical intervention to the affected knee
  • Local or systemic infection
  • Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
  • Significant abnormal laboratory tests that contraindicates participation in the trial.
  • Pregnant women or intend to become pregnant or breast-feeding
  • Neoplastic process within the previous 5 years or without complete remission.
  • The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  • Legally dependant patient.
  • The patient does not accept to be followed-up for a period that could exceed the clinical trial length

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICATME-Hospital Quiron Dexeus

Barcelona, 08028, Spain

Location

Related Links

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Joan Carles Monllau, MD, PhD

    ICATME-Hospital Quiron Dexeus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 10, 2014

Study Start

January 31, 2014

Primary Completion

May 2, 2017

Study Completion

May 2, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

ES(1)