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Treatment of Knee Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT02123368
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

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:

  1. Group A: intra-articular injection of hyaluronic acid (Hyalone®). Single dose.
  2. Group B: Low Dosage of MSCs . Intra-articular injection of 10 million autologous mesenchymal progenitor stem cells cultured ex - vivo (cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid ( Hyalone®).
  3. Group C : High dose of MSCs. Intra-articular injection of 100 million autologous mesenchymal progenitor stem cells cultured ex - vivo ( cell suspension sterile small volume (5-10 ml ) in a vehicle suitable for intraarticular injection ) followed by an intraarticular injection Hiaurónico Acid (Hyalone®).

The primary endpoint is safety and feasibility. The investigators registered the occurrence of complications and / or adverse effects during the study.

In addition the investigators assess the response to intra-articular infusion of CMM analyzing the following parameters:

  • 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Hyaluronic acid Biological: 10 million Bone marrow mesenchimal stem cells Biological: 100 million Bone marrow mesenchimal stem cells Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Osteoarthritis by Intra-articular Injection of Bone Marrow Mesenchymal Stem Cells
Study Start Date : May 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Hialuronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
Drug: Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
Other Name: HyalOne

Active Comparator: Hyaluronic acid and MSC 10
Single intraarticular injection of Hyaluronic acid (Hyal One) 10 million Bone marrow mesenchimal stem cells
Drug: Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
Other Name: HyalOne

Biological: 10 million Bone marrow mesenchimal stem cells
10 million of Bone marrow mesenchimal stem cells

Active Comparator: Hyaluronic acid AND MSC 100
Single intraarticular injection of Hyaluronic acid (Hyal One) 100 million Bone marrow mesenchimal stem cells
Drug: Hyaluronic acid
Single intraarticular injection of Hyaluronic acid (Hyal One)
Other Name: HyalOne

Biological: 100 million Bone marrow mesenchimal stem cells
100 million of Bone marrow mesenchimal stem cells




Primary Outcome Measures :
  1. Baseline Visual analogue scale (VAS) [ Time Frame: prior to the initial dose on day 1 ]
    Baseline Visual analogue scale (VAS)

  2. Baseline value of knee injury and osteoarthritis outcome score (Koos). [ Time Frame: Prior to the intervention on day 1 ]
    Prior to the intervention on day 1 value of knee injury and osteoarthritis outcome score (Koos).

  3. Baseline Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC). [ Time Frame: Prior to the intervention on day 1 ]
    Prior to the intervention on day 1 Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC).

  4. Baseline SF-36 value [ Time Frame: Prior to the intervention on day 1 ]
    Prior to the intervention on day 1 SF-36 value

  5. Baseline euroquol 5D value [ Time Frame: Prior to the intervention on day 1 ]
    Pretreatment euroquol 5D value

  6. Baseline Lequesne index [ Time Frame: Prior to the intervention on day 1 ]
    Prior to the intervention on day 1 Lequesne index

  7. Baseline femorotibial distance [ Time Frame: Prior to the intervention ]
    Prior to the intervention femoritibial distance on rosenberg x-ray view

  8. 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 [ Time Frame: Follow up ]
    During the follow up

  9. Visual analogue scale (VAS) at on month [ Time Frame: 1 month ]
    Visual analogue scale (VAS) at on month

  10. Visual analogue scale (VAS) at 3 months [ Time Frame: 3 months ]
    Visual analogue scale (VAS) at 3 months

  11. Visual analogue scale (VAS) at 6 months [ Time Frame: 6 months ]
    Visual analogue scale (VAS) at 6 months

  12. Visual analogue scale (VAS) at 12 months [ Time Frame: 12 months ]
    Visual analogue scale (VAS) at 12 months

  13. Value of knee injury and osteoarthritis outcome score (Koos) at 1 month [ Time Frame: 1 month ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 1 month

  14. Value of knee injury and osteoarthritis outcome score (Koos) at 3 month [ Time Frame: 3 Months ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 3 month

  15. Value of knee injury and osteoarthritis outcome score (Koos) at 6 month [ Time Frame: 6 months ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 6 month

  16. Value of knee injury and osteoarthritis outcome score (Koos) at 12 months [ Time Frame: 12 months ]
    Value of knee injury and osteoarthritis outcome score (Koos) at 12 months

  17. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month [ Time Frame: 1 month ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

  18. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 3 month [ Time Frame: 3 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 1 month

  19. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month [ Time Frame: 6 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 6 month

  20. Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months [ Time Frame: 12 months ]
    Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) at 12 months

  21. SF-36 value at 1 month [ Time Frame: 1 month ]
    SF-36 value

  22. SF 36 value at 3 months [ Time Frame: 3 months ]
    SF 36 value at 3 months

  23. SF 36 value at 6 months [ Time Frame: 6 months ]
    SF 36 value at 6 months

  24. SF 36 value at 12 months [ Time Frame: 12 months ]
    SF 36 value at 12 months

  25. Euroquol 5D value at 1 month [ Time Frame: 1 MOnth ]
    Euroquol 5D value at 1 month

  26. Euroquol 5D value at 3 months [ Time Frame: 3 months ]
    Euroquol 5D value at 3 months

  27. Euroquol 5D value at 6 months [ Time Frame: 6 months ]
    Euroquol 5D value at 6 months

  28. Euroquol 5D value at 12 months [ Time Frame: 12 months ]
    Euroquol 5D value at 12 months

  29. Lequesne index at 1 month [ Time Frame: 1 month ]
    Lequesne index at 1 month

  30. Lequesne index at 3 months [ Time Frame: 3 months ]
    Lequesne index at 3 months

  31. Lequesne index at 6 months [ Time Frame: 6 months ]
    Lequesne index at 6 months

  32. Lequesne index at 12 months [ Time Frame: 12 months ]
    Lequesne index at 12 months

  33. Femorotibial distance at 6 months [ Time Frame: 6 months ]
    Femorotibial distance at 6 months

  34. Femorotibial distance at 12 months [ Time Frame: 12 months ]
    Femorotibial distance at 12 months

  35. Baseline MRI WORMS protocol [ Time Frame: Prior to the intervention ]
    Prior to the intervention MRI WORMS protocol

  36. MRI WORMS protocol score at 6 months [ Time Frame: 6 months ]
    MRI WORMS protocol score at 6 months

  37. MRI WORMS protocol score at 12 months [ Time Frame: 12 months ]
    MRI WORMS protocol score at 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Treatment with corticosteroids in the 3 months prior to inclusion in the study.
  • NSAID therapy within 15 days prior to inclusion in the study.
  • Patients with a history of allergy to penicillin or streptomycin.
  • Allergy to hyaluronic acid or poultry proteins.

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): NCT02123368


Locations
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Spain
Traumatology department. Complejo Hospitalario de Salamanca
Salamanca, Castilla y León, Spain, 37007
Orthopaedic and traumatology department. Clínica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: José Lamo-Espinosa, MD Clinica Universidad de Navarra
Study Director: Felipe Prosper, MD PhD Clinica Universidad de Navarra
Principal Investigator: Juan Blanco, MD PhD Hospital Universitario de Salamanca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02123368     History of Changes
Other Study ID Numbers: CMM/ART
2009-017624-72 ( EudraCT Number )
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Osteoarthritis
Mesenchimal stem cell
Knee
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents