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

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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Recruitment Status : Withdrawn (No enrollment)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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: Trophic factors from umbilical cord mesenchymal stem cells Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of Mesenchymal Trophic Factor (MTF) for Treatment of Osteoarthritis
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Intra-articular knee injection of MTF
Trophic factors from umbilical cord mesenchymal stem cells administered intra-articularly.
 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.
 Biological: Trophic factors from umbilical cord mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of participants with a change in joint function from baseline WOMAC assessment at 12 months [ Time Frame: 12 months ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02003131


Locations
Panama
Stem Cell Institute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
Principal Investigator: Jorge Paz-Rodriguez, MD Translational Biosciences / Stem Cell Institute
More Information
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Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT02003131     History of Changes
Other Study ID Numbers: TBS-MTFOA-001
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Translational Biosciences:
osteoarthritis
umbilical cord
mesenchymal
stem cells
trophic factors

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases