NCT02123368

Brief Summary

Purpose: To determine the safety, feasibility and effectiveness (clinical and radiological) of intra-articular administration of autologous mesenchymal stem cells (MSCs) in patients with knee osteoarthritis. Patients and methods Clinical trial phase I- II, randomized , multicenter , with three treatment arms and 10 patients for each group. The investigators compare the intraarticular injection of hialuronic acid against the administration of two different doses of mesenchymal stem cells with hialuronic acid according to the following scheme:

  • Clinical assessment of pain and function (Baseline, 1, 3, 6 and 12 months since treatment): VAS , WOMAC , KOOS , EuroQol, SF-16, Lequesne , WOMAC , KOOS.
  • Radiographic (baseline, 6 and 12 months since treatment): Femorotibial space.
  • Radiographic using MRI (baseline, 6 and 12 months since treatment): by assessing the number location of the lesions , cartilage thickness , signal intensity , subchondral bone alteration , volume and WORMS and dGEMRIC protocols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

May 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

2.5 years

First QC Date

November 12, 2013

Last Update Submit

October 23, 2017

Conditions

Osteoarthritis

Keywords

OsteoarthritisMesenchimal stem cellKnee

Outcome Measures

Primary Outcomes (37)

  • Baseline Visual analogue scale (VAS)

    Baseline Visual analogue scale (VAS)

    prior to the initial dose on day 1

  • Baseline value of knee injury and osteoarthritis outcome score (Koos).

    Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).

    Prior to the intervention on day 1

  • Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).

    Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).

    Prior to the intervention on day 1

  • Baseline SF-36 value

    Prior to the intervention on day 1 SF-36 value

    Prior to the intervention on day 1

  • Baseline euroquol 5D value

    Pretreatment euroquol 5D value

    Prior to the intervention on day 1

  • Baseline Lequesne index

    Prior to the intervention on day 1 Lequesne index

    Prior to the intervention on day 1

  • Baseline femorotibial distance

    Prior to the intervention femoritibial distance on rosenberg x-ray view

    Prior to the intervention

  • Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events Number of Participants with Serious and Non-Serious Adverse Events

    During the follow up

    Follow up

  • Visual analogue scale (VAS) at on month

    Visual analogue scale (VAS) at on month

    1 month

  • Visual analogue scale (VAS) at 3 months

    Visual analogue scale (VAS) at 3 months

    3 months

  • Visual analogue scale (VAS) at 6 months

    Visual analogue scale (VAS) at 6 months

    6 months

  • Visual analogue scale (VAS) at 12 months

    Visual analogue scale (VAS) at 12 months

    12 months

  • Value of knee injury and osteoarthritis outcome score (Koos) at 1 month

    Value of knee injury and osteoarthritis outcome score (Koos) at 1 month

    1 month

  • Value of knee injury and osteoarthritis outcome score (Koos) at 3 month

    Value of knee injury and osteoarthritis outcome score (Koos) at 3 month

    3 Months

  • Value of knee injury and osteoarthritis outcome score (Koos) at 6 month

    Value of knee injury and osteoarthritis outcome score (Koos) at 6 month

    6 months

  • Value of knee injury and osteoarthritis outcome score (Koos) at 12 months

    Value of knee injury and osteoarthritis outcome score (Koos) at 12 months

    12 months

  • Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

    1 month

  • Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

    3 months

  • Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month

    6 months

  • Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months

    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months

    12 months

  • SF-36 value at 1 month

    SF-36 value

    1 month

  • SF 36 value at 3 months

    SF 36 value at 3 months

    3 months

  • SF 36 value at 6 months

    SF 36 value at 6 months

    6 months

  • SF 36 value at 12 months

    SF 36 value at 12 months

    12 months

  • Euroquol 5D value at 1 month

    Euroquol 5D value at 1 month

    1 MOnth

  • Euroquol 5D value at 3 months

    Euroquol 5D value at 3 months

    3 months

  • Euroquol 5D value at 6 months

    Euroquol 5D value at 6 months

    6 months

  • Euroquol 5D value at 12 months

    Euroquol 5D value at 12 months

    12 months

  • Lequesne index at 1 month

    Lequesne index at 1 month

    1 month

  • Lequesne index at 3 months

    Lequesne index at 3 months

    3 months

  • Lequesne index at 6 months

    Lequesne index at 6 months

    6 months

  • Lequesne index at 12 months

    Lequesne index at 12 months

    12 months

  • Femorotibial distance at 6 months

    Femorotibial distance at 6 months

    6 months

  • Femorotibial distance at 12 months

    Femorotibial distance at 12 months

    12 months

  • Baseline MRI WORMS protocol

    Prior to the intervention MRI WORMS protocol

    Prior to the intervention

  • MRI WORMS protocol score at 6 months

    MRI WORMS protocol score at 6 months

    6 months

  • MRI WORMS protocol score at 12 months

    MRI WORMS protocol score at 12 months

    12 months

Study Arms (3)

Hialuronic acid

ACTIVE COMPARATOR

Single intraarticular injection of Hyaluronic acid (Hyal One)

Drug: Hyaluronic acid

Hyaluronic acid and MSC 10

ACTIVE COMPARATOR

Single intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells

Drug: Hyaluronic acidBiological: 10 million Bone marrow mesenchimal stem cells

Hyaluronic acid AND MSC 100

ACTIVE COMPARATOR

Single intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells

Drug: Hyaluronic acidBiological: 100 million Bone marrow mesenchimal stem cells

Interventions

Hyaluronic acidDRUG

Single intraarticular injection of Hyaluronic acid (Hyal One)

Also known as: HyalOne
Hialuronic acidHyaluronic acid AND MSC 100Hyaluronic acid and MSC 10
10 million Bone marrow mesenchimal stem cellsBIOLOGICAL

10 million of Bone marrow mesenchimal stem cells

Hyaluronic acid and MSC 10
100 million Bone marrow mesenchimal stem cellsBIOLOGICAL

100 million of Bone marrow mesenchimal stem cells

Hyaluronic acid AND MSC 100

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 50 and 80 year old.
  • Diagnosis of knee OA according to the criteria of osteoarthritis of the ACR (American College of Rheumatology).
  • Joint pain equal or greater than 2.5 points on the visual analogue scale (VAS).
  • Radiological Classification: Kellgren-Lawrence scale greater or equal to 2.
  • Body mass index between 20 and 35 kg/m2.
  • Ability to follow during the study period.

You may not qualify if:

  • Bilateral Osteoarthritis of the Knee requiring treatment in both knees.
  • Previous diagnosis of polyarticular disease.
  • Severe mechanical deformation.
  • Arthroscopy during the previous 6 months.
  • Intraarticular infiltration of hyaluronic acid in the last 6 months.
  • Systemic autoimmune rheumatic disease.
  • Poorly controlled diabetes mellitus.
  • Blood dyscrasias.
  • Immunosuppressive or anticoagulant treatments.
  • Patients with a history of allergy to penicillin or streptomycin.
  • Allergy to hyaluronic acid or poultry proteins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Traumatology department. Complejo Hospitalario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Orthopaedic and traumatology department. Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (3)

  • Lamo-Espinosa JM, Prosper F, Blanco JF, Sanchez-Guijo F, Alberca M, Garcia V, Gonzalez-Vallinas M, Garcia-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2.

    PMID: 34895259DERIVED

  • Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Lopez-Elio S, Andreu E, Sanchez-Guijo F, Aquerreta JD, Bondia JM, Valenti-Azcarate A, Del Consuelo Del Canizo M, Villaron EM, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: long-term follow up of a multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2018 Jul 31;16(1):213. doi: 10.1186/s12967-018-1591-7.

    PMID: 30064455DERIVED

  • Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.

    PMID: 27565858DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • José Lamo-Espinosa, MD

    Clinica Universidad de Navarra

    PRINCIPAL INVESTIGATOR

  • Felipe Prosper, MD PhD

    Clinica Universidad de Navarra

    STUDY DIRECTOR

  • Juan Blanco, MD PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

April 25, 2014

Study Start

May 1, 2012

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

ES(2)