Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 277 for:    Panama

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01885832
Recruitment Status : Withdrawn (per sponsor decision)
First Posted : June 25, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Autologous adipose tissue stromal vascular fraction Phase 1 Phase 2

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Study Start Date : June 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Treatment
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.
Biological: Autologous adipose tissue stromal vascular fraction



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline Kellgren-Lawrence classification at 6 months [ Time Frame: 6 months ]
  2. Change from baseline WOMAC Assessment at 6 months [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885832


Locations
Layout table for location information
Panama
Stem Cell Instsitute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
Layout table for investigator information
Principal Investigator: Jorge Paz-Rodriguez, M.D. Stem Cell Institute Panama

Layout table for additonal information
Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT01885832     History of Changes
Other Study ID Numbers: TBS-SVF-OA-002-2013
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Translational Biosciences:
autologous adipose stem cells
stromal vascular fraction
osteoarthritis

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases