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

NCT ID: NCT02003131

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2019-06-30

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).

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-articular knee injection of MTF

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

Group Type: OTHER

Trophic factors from umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Subcutaneous injection of MTF

Trophic factors from umbilical cord mesenchymal stem cells administered subcutaneously once per week for 12 weeks.

Group Type: OTHER

Trophic factors from umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Interventions

Trophic factors from umbilical cord mesenchymal stem cells

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Translational Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Paz-Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Biosciences / Stem Cell Institute

Locations

Stem Cell Institute

Panama City, , Panama

Countries

Panama

Other Identifiers

TBS-MTFOA-001

Identifier Type: -

Identifier Source: org_study_id