Back to results

Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

Primary Purpose

Osteoarthritis

Status

Withdrawn

Phase

Phase 1

Locations

Panama

Study Type

Interventional

Intervention

Autologous adipose tissue stromal vascular fraction

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring autologous adipose stem cells, stromal vascular fraction, osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

Age >18 years and ability to understand the planned treatment.

Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification

Ability and willingness to undergo liposuction

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 postinfectious 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.

Intraarticular 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 Instsitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

In the treatment arm, autologous stromal vascular fraction (SVF) will be injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity.

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Change from baseline Kellgren-Lawrence classification at 6 months

Change from baseline WOMAC Assessment at 6 months

Full Information

NCT ID

NCT01885832

First Posted

June 18, 2013

Last Updated

August 8, 2017

Sponsor

Translational Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT01885832

Brief Title

Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

Official Title

Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Withdrawn

Why Stopped

per sponsor decision

Study Start Date

June 2013 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

December 2016 (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

Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment associated adverse events. Improvements in joint function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.

Detailed Description

The proposed study is a single center, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) isolated from 500 ml of adipose tissue extracted from the infraumbilical area. The cellular product will be administered via intra-articular injection into patients with moderate to severe osteoarthritis (OA). Administration will be performed by injection into the synovial space. The dosing regimen will consist of two intraarticular injection of autologous SVF into the index knee. Total injection volume will be about 30 mL in two 15 mL aliquots via a 23 gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7). The purpose of this study will be to define the safety and efficacy of SVF therapy in improving joint function and the quality of life in patients with OA of the knee. We plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. The primary safety outcome will be tabulation of adverse events related to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total 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

Keywords

autologous adipose stem cells, stromal vascular fraction, osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

In the treatment arm, autologous stromal vascular fraction (SVF) will be injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity.

Intervention Type

Biological

Intervention Name(s)

Autologous adipose tissue stromal vascular fraction

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change from baseline Kellgren-Lawrence classification at 6 months

Time Frame

6 months

Title

Change from baseline WOMAC Assessment at 6 months

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >18 years and ability to understand the planned treatment. Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification Ability and willingness to undergo liposuction 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 postinfectious 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. Intraarticular 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, M.D.

Organizational Affiliation

Stem Cell Institute Panama

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stem Cell Instsitute

City

Panama City

Country

Panama

12. IPD Sharing Statement

Learn more about this trial

Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

We'll reach out to this number within 24 hrs