Back to results

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

Primary Purpose

Osteoarthritis of the Knee

Status

Withdrawn

Phase

Phase 1

Locations

Panama

Study Type

Interventional

Intervention

Trophic factors from umbilical cord mesenchymal stem cells

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, umbilical cord, mesenchymal, stem cells, trophic factors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stem Cell Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intra-articular knee injection of MTF

Subcutaneous injection of MTF

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02003131

First Posted

December 2, 2013

Last Updated

August 8, 2017

Sponsor

Translational Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT02003131

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Withdrawn

Why Stopped

No enrollment

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Translational Biosciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intra-articular knee injection of MTF

Arm Type

Other

Arm Description

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

Arm Title

Subcutaneous injection of MTF

Arm Type

Other

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Trophic factors from umbilical cord mesenchymal stem cells

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Time Frame

12 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Paz-Rodriguez, MD

Organizational Affiliation

Translational Biosciences / Stem Cell Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stem Cell Institute

City

Panama City

Country

Panama

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs