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Osteoarthritis, KneePhase 1/2MSV_alloNCT01586312

Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

A Phase 1/2 study testing Allogenic mesenchymal stromal cells injection and Hyaluronic Acid in people with Osteoarthritis, Knee and Arthritis of Knee, run by Red de Terapia Celular at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Allogenic mesenchymal stromal cells injection and Hyaluronic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesSpain
Study dates
Apr 2012to Jun 2014
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
  • Chronic knee pain with mechanical characteristics.
  • No local or systemic septic process.
  • Haematological and biochemical analysis without significant alterations that contraindicate treatment.
  • Informed written consent of the patient.
  • The patient is able to understand the nature of the study

Who cannot join

  • Age over 75 or under 18 years or legally dependent
  • Present Infection (to be included in the study no signs of infection must be evidenced)
  • Congenital or acquired malformation resulting in significant deformity of the knee (varus<10º; valgus<20º) and leading to problems in application or evaluation of results.
  • Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
  • Women who are pregnant or intend to become pregnant or breast-feeding
  • Neoplasia
Show all 10Show fewer
  • Immunosuppressive states
  • Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion
  • Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Centro Medico Teknon

    Barcelona, Barcelona, 08022

  • Hospital Clinico Universitario

    Valladolid, Valladolid, 47003

Other trials in Spain

About this study

Official title: Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid

In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.

Being tested
Allogenic mesenchymal stromal cells injection, Hyaluronic Acid
Keywords
Knee degenerative disease, osteoarthritis, gonarthrosis, stem cell, cellular therapy, regenerative therapy, Mesenchymal stem cells, Bone marrow, musculoskeletal Diseases, Mesenchymal Stromal Cells (allogenic)
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic mesenchymal stromal cells injectionOther

    Also called MSV, Mesenchymal Stem Cells, MSC

    Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency

  • Hyaluronic AcidDrug

    Also called Hyaluronic acid, durolane, CE mark:516407

    Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)

Study groups in NCT01586312
Study groupRoleWhat they receive
Allogenic mesenchymal stromal cells injectionExperimentalMesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
Receives: Other: Allogenic mesenchymal stromal cells injection
Hyaluronic acid (Durolane)Active comparatorIntraarticular injection of hyaluronic acid (60 mg)
Receives: Drug: Hyaluronic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months

    Measured: Up to one year

Secondary outcomes (2)

  1. Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)

    Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.

    WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.

    SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.

    The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.

    LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).

    All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.

    Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales.

    Measured: up to one year

  2. Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)

    Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.

    Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88.

    Measured: up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586312
Sponsor's protocol ID
TerCel004
Other IDs
2011-005321-51, EC11-309, MSV_allo
Acronym
MSV_allo
Status last verified
Sep 2015
First submitted
23 Apr 2012
Last updated
16 Oct 2015
Data monitoring committee
Yes

Publications

  • Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.

    PubMed 21792091

  • Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study. Transplantation. 2013 Jun 27;95(12):1535-41. doi: 10.1097/TP.0b013e318291a2da.

    PubMed 23680930

  • Orozco L, Munar A, Soler R, Alberca M, Soler F, Huguet M, Sentis J, Sanchez A, Garcia-Sancho J. Treatment of knee osteoarthritis with autologous mesenchymal stem cells: two-year follow-up results. Transplantation. 2014 Jun 15;97(11):e66-8. doi: 10.1097/TP.0000000000000167. No abstract available.

    PubMed 24887752

  • Vega A, Martin-Ferrero MA, Del Canto F, Alberca M, Garcia V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sanchez A, Garcia-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678.

    PubMed 25822648

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogenic mesenchymal stromal cells injection and Hyaluronic Acid in people with Osteoarthritis, Knee and Arthritis of Knee, run by Red de Terapia Celular at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586312, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.

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