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ADIPOA - Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01585857
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE March 19, 2012
First Posted Date  ICMJE April 26, 2012
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
Recording of Serious Adverse Events [ Time Frame: during 365 days following injection ]
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2012)
  • Functional status of the knee [ Time Frame: during 365 days following injection ]
    Efficacy will be assessed by measuring:
    • WOMAC (Western Ontario and McMaster Universities osteoarthritis index),
    • Short Arthritis assessment Scale (SAS),
    • range of motion of the target knee joint,
    • imaging through MRI evaluation, dGEMRIC and T1rho MRI.
  • Quality of life [ Time Frame: during 365 days following injection ]
    Quality of life will be assessed by measuring:
    • pain-specific assessment
    • global patient assessment (visual analog scale, Short-Form 8)
    • decrease in rescue paracetamol medication.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADIPOA - Clinical Study
Official Title  ICMJE A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint
Brief Summary

Primary:

To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

Secondary:

To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Biological: Autologous adipose derived stem cells administrated for intra-articular use
    Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.
  • Biological: Autologous adipose derived stem cells administrated for intra-articular use
    Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.
Study Arms  ICMJE
  • Experimental: Group 1
    2 x 10E6 ASC intra-articular injection (5 ml)
    Intervention: Biological: Autologous adipose derived stem cells administrated for intra-articular use
  • Experimental: Group 2
    10 x 10E6 ASC intra-articular injection (5 ml)
    Intervention: Biological: Autologous adipose derived stem cells administrated for intra-articular use
  • Experimental: Group 3
    50 x 10E6 ASC intra-articular injection (5 ml)
    Intervention: Biological: Autologous adipose derived stem cells administrated for intra-articular use
Publications * Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noël D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2012)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.

Exclusion Criteria:

  • Any disease or medication affecting the bone or cartilage metabolism, including corticoids.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01585857
Other Study ID Numbers  ICMJE 8606
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Jorgensen, MD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP