Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis

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: NCT02003131
Recruitment Status : Withdrawn (No enrollment)
First Posted : December 6, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date August 10, 2017
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Number of participants with adverse events [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02003131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • Number of participants with a change in joint function from baseline WOMAC assessment at 12 months [ Time Frame: 12 months ]
  • Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system at 12 months [ Time Frame: 12 months ]
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 Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
Official Title  ICMJE Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
Brief Summary Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) injected into the knee joints of 20 patients (group 1) or injected subcutaneously into 20 patients (group 2) is a safe and useful procedure for inducing joint function improvements in osteoarthritis (OA) patients with grade 2, 3, or 4 radiographic OA severity.
Detailed Description

The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to two arms osteoarthritis patients with grade 2, 3, or 4 radiographic OA severity (20 per arm). The first arm will receive an intra-articular injection of MTF into the knee joint under fluoroscopy. The second arm will receive 12 subcutaneous MTF injections, once per week.

For both arms, the primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of joint function improvement as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE Biological: Trophic factors from umbilical cord mesenchymal stem cells
Study Arms  ICMJE
  • Intra-articular knee injection of MTF
    Trophic factors from umbilical cord mesenchymal stem cells administered intra-articularly.
    Intervention: Biological: Trophic factors from umbilical cord mesenchymal stem cells
  • Subcutaneous injection of MTF
    Trophic factors from umbilical cord mesenchymal stem cells administered subcutaneously once per week for 12 weeks.
    Intervention: Biological: Trophic factors from umbilical cord mesenchymal stem cells
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2013)
40
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >18 years and ability to understand the planned treatment.
  • Subjects 18 years of age or older with idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification

Exclusion Criteria:

  • Pregnant women or cognitively impaired adults.
  • Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
  • Inflammatory or post infectious arthritis.
  • More than 5 degrees of varus or valgus deformity.
  • Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
  • Intra-articular corticosteroid injection within the previous 3 months.
  • A major neurologic deficit.
  • Serious medical illness with a life expectancy of less than 1 year.
  • Prior admission for substance abuse
  • Body Mass Index (BMI) of 40 kg/m2 or greater
  • Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
  • In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003131
Other Study ID Numbers  ICMJE TBS-MTFOA-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Translational Biosciences
Study Sponsor  ICMJE Translational Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Paz-Rodriguez, MD Translational Biosciences / Stem Cell Institute
PRS Account Translational Biosciences
Verification Date August 2017

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