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

NCT02003131 | Withdrawn Phase 1 DMC

• 1 other identifier: TBS-MTFOA-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; umbilical cord; mesenchymal; stem cells; trophic factors

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  12 months

Secondary Outcomes (2)

• Number of participants with a change in joint function from baseline WOMAC assessment at 12 months

  12 months

• Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system at 12 months

  12 months

Study Arms (2)

Intra-articular knee injection of MTF

OTHER

Trophic factors from umbilical cord mesenchymal stem cells administered intra-articularly.

Biological: Trophic factors from umbilical cord mesenchymal stem cells

Subcutaneous injection of MTF

OTHER

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

Interventions

Trophic factors from umbilical cord mesenchymal stem cells BIOLOGICAL

Intra-articular knee injection of MTF; Subcutaneous injection of MTF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Biosciences: lead

Study Sites (1)

Stem Cell Institute

Panama City, Panama

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jorge Paz-Rodriguez, MD

  Translational Biosciences / Stem Cell Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

PA (1)