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Osteoarthritis, KneePhase 1/2NCT01227694

Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

A Phase 1/2 study testing Autologous MSC knee implantation in people with Osteoarthritis, Knee and Knee Injuries, run by Banc de Sang i Teixits at 1 site 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

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Autologous MSC knee implantation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSpain
Study dates
Oct 2010to Jan 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
  • Chronic knee pain with mechanical characteristics
  • Absence of local or systemic septic process
  • Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
  • Informed Consent form signed by the patient
  • The patient is able to understand the nature of the study

Who cannot join

  • Patients < 18 years or legally dependent
  • Patients >65 years
  • Previous surgery of the knee
  • Intraarticular treatment in the past 6 month
  • Knee ligament or meniscus rupture observed by MRI
  • Any sign of infection
Show all 14Show fewer
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
  • Congenital or acquired malformation resulting in significant deformity of the knee 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).
  • Pregnant women or intend to become pregnant or breast-feeding
  • Neoplasia
  • Immunosuppressive states
  • 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

1 site in 1 country.

Spain1 site

  • Centro Medico Teknon-ITRT

    Barcelona, 08022

Other trials in Spain

About this study

Official title: Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires.

MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month.

The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.

Being tested
Autologous MSC knee implantation
Keywords
Cell therapy, Regenerative therapy, Advance therapy, Bone marrow, Mesenchymal stem cell, Autologous, Interventional clinical trial, Osteoarthrosis, Osteoarthritis, Knee
Medical subject headings
Osteoarthritis, Knee, Knee Injuries, Joint Diseases, Rheumatic Diseases, Cartilage Diseases, Osteoarthritis

What participants receive

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

  • Autologous MSC knee implantationOther

    Also called Xcel-m-condro-alpha

    Isolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.

Study groups in NCT01227694
Study groupRoleWhat they receive
Autologous MSC knee implantationExperimentalIsolation and "Ex-Vivo" expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias Avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection.
Receives: Other: Autologous MSC knee implantation

What is being measured

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

  1. Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.

    Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable.

    Measured: 12 months

  2. Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.

    Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.

    Measured: 12 months

Secondary outcomes (5)

  1. Efficacy by imaging procedures.

    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).

    Measured: 6 months

  2. Efficacy by imaging procedures.

    Articular cartilage changes will be determined by T2-weighted MRI (Cartigram).

    Measured: 12 month

  3. Clinical outcomes.

    Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36).

    Measured: 3 month

  4. Clinical outcomes.

    Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36).

    Measured: 6 months

  5. Clinical outcomes.

    Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36).

    Measured: 12 months

Timeline

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

  1. First posted25 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJul 2012
  4. Study completionJan 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01227694
Sponsor's protocol ID
XCEL-M-09-01
Status last verified
Nov 2015
First submitted
22 Oct 2010
Last updated
11 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.

    PubMed 25769789

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous MSC knee implantation in people with Osteoarthritis, Knee and Knee Injuries, run by Banc de Sang i Teixits at 1 site 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 14 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01227694, which also lists 1 linked publication.

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 11 Dec 2015.

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