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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02003131
• Other study ID #: TBS-MTFOA-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: December 2, 2013
• Last updated: August 8, 2017
• Start date: December 2013
• Est. completion date: June 2019

Study information

• Verified date: August 2017
• Source: Translational Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Biological:
• Trophic factors from umbilical cord mesenchymal stem cells

Locations

Country	Name	City	State
Panama	Stem Cell Institute	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Translational Biosciences

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		12 months
Secondary	Number of participants with a change in joint function from baseline WOMAC assessment at 12 months		12 months
Secondary	Number of participants with a change in radiogrpahic evidence of knee OA from baseline Kellegren-Lawrence grading system at 12 months		12 months