Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-07

Study Completion Date

2021-01-31

Brief Summary

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The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.

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Detailed Description

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Conditions

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Knee Osteoarthritis

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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PSC-01

All study participants will receive intraarticular injection of the investigational biological product, PSC-01.

Group Type EXPERIMENTAL

PSC-01

Intervention Type DRUG

PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.

Interventions

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PSC-01

PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* If a woman of childbearing potential, the study participant must not be pregnant at the time of consent and must take contraceptive measures to prevent a pregnancy while actively participating in the study
* The study participant may be of any gender or ethnic background.
* Must experience knee pain at least weekly for at least 3 months.
* Must have failed a minimum of 6 weeks of first line, conservative therapy
* Demonstrated clinical and radiographic evidence of OA diagnosis
* Grade 2, 3, or 4 Kellgren-Lawrence score in one knee.
* Normal or within protocol approved limits of laboratory blood and urinalysis tests
* Must be suitable for cellular therapy per the Investigator's opinion
* Must be suitable for liposuction per the Investigator's opinion
* Must possess the cognitive ability to understand the investigational nature of this clinical trial and voluntarily provide consent for study participation

Exclusion Criteria

* Evidence of OA in the contralateral knee with a Kellgren-Lawrence score greater than 2
* If a woman of child-bearing potential, the study participant must not be pregnant or attempt to become pregnant while actively taking part in the study.
* Steroid injection in either knee within 60 days of providing informed consent
* The subject must not be diagnosed with any of the following diseases at the time of consent:

* Osteonecrosis
* Active autoimmune disease
* Serious cardiac condition
* Psychotic Diseases
* Epilepsy
* Uncontrolled diabetes
* Prescribed immunosuppressive therapy at the time of consent
* Evidence of cancer at the time of consent
* History of alcohol or substance abuse
* Regular smoker at the time of consent
* Received experimental medication or participated in another clinical study within 60 days of providing informed consent
* Concurrent diseases or circumstances that the Investigator judges to be a potential risk to patient health or a confounding variable in the assessment of study endpoints.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No