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ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

NCT ID: NCT02357485

Last Updated: 2015-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.

Detailed Description

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This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.

Conditions

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Osteoarthritis of the Knee

Keywords

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ADSC osteoarthritis knee adipose

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Single injection of ADSC

Group Type EXPERIMENTAL

ADSC

Intervention Type BIOLOGICAL

Single injection of ADSC

Interventions

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ADSC

Single injection of ADSC

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* voluntarily provided written Informed Consent
* ages 20-70
* male or female
* grades I-III radiologically documented OA of one or both knees
* American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
* knee pain graded as greater than 3 out of 10 on screening questionnaire
* able to speak, read and understand English -

* current oral or parenteral steroid or blood thinner use
* hyaluronic acid-based injection to the affected knee joint within the previous six months
* corticosteroid injection to the affected knee joint within the previous three months
* end stage (Grade IV) OA
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Plastic Surgery Education and Research Foundation

UNKNOWN

Sponsor Role collaborator

Fodor, Peter B, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Peter B. Fodor MD

Peter B. Fodor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter B Fodor, M.D.

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Other Identifiers

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OAKnee01

Identifier Type: -

Identifier Source: org_study_id