search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PSC-01
Sponsored by
Personalized Stem Cells, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring cellular therapy, stromal vascular fraction, SVF, KOOS, autologous, mesenchymal stem cell, MSC, knee, osteoarthritis, adipose-derived mesenchymal stem cells, Ad-MSC, intraarticular

Eligibility Criteria

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

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.

Sites / Locations

  • San Diego Orthobiologics Medical Group
  • Grossmont Orthopedic Medical Group
  • Synergy Orthopedic Specialists Medical Group
  • The Orthohealing Center
  • Cellular Orthopedics
  • New Jersey Regenerative Institute
  • RestorePDX

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PSC-01

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Adverse Events
The primary outcome measure of this study is to evaluate the safety of the investigational biological product, PSC-01.Safety will be assessed as the number of treatment-related adverse events as assessed by CTCAE v5.0. Adverse events will be assessed by physical examination, patient-reported health status, clinical pathology evaluations (cbc, chemistry, and urinalysis), and post-procedure clinical observations through the 84-day study period with post-treatment follow-up at 6 and 12 months.

Secondary Outcome Measures

Changes in KOOS Measurement
The secondary outcome measure of this study is to obtain initial data on the efficacy of PSC-01 on treating knee osteoarthritis. The efficacy primary outcome will be assessed using the KOOS knee survey with the five relevant subcategories of pain, symptoms, average daily living, sport/recreation, and quality of life measured at baseline, day 42 and day 84.

Full Information

First Posted
July 23, 2019
Last Updated
September 14, 2020
Sponsor
Personalized Stem Cells, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04043819
Brief Title
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
Official Title
Evaluation of Safety and Exploratory Efficacy of PSC-01, an Autologous Adipose-derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Personalized Stem Cells, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
cellular therapy, stromal vascular fraction, SVF, KOOS, autologous, mesenchymal stem cell, MSC, knee, osteoarthritis, adipose-derived mesenchymal stem cells, Ad-MSC, intraarticular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSC-01
Arm Type
Experimental
Arm Description
All study participants will receive intraarticular injection of the investigational biological product, PSC-01.
Intervention Type
Drug
Intervention Name(s)
PSC-01
Intervention Description
PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
The primary outcome measure of this study is to evaluate the safety of the investigational biological product, PSC-01.Safety will be assessed as the number of treatment-related adverse events as assessed by CTCAE v5.0. Adverse events will be assessed by physical examination, patient-reported health status, clinical pathology evaluations (cbc, chemistry, and urinalysis), and post-procedure clinical observations through the 84-day study period with post-treatment follow-up at 6 and 12 months.
Time Frame
3-4 months
Secondary Outcome Measure Information:
Title
Changes in KOOS Measurement
Description
The secondary outcome measure of this study is to obtain initial data on the efficacy of PSC-01 on treating knee osteoarthritis. The efficacy primary outcome will be assessed using the KOOS knee survey with the five relevant subcategories of pain, symptoms, average daily living, sport/recreation, and quality of life measured at baseline, day 42 and day 84.
Time Frame
3-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
San Diego Orthobiologics Medical Group
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Grossmont Orthopedic Medical Group
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Synergy Orthopedic Specialists Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
The Orthohealing Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Cellular Orthopedics
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
New Jersey Regenerative Institute
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
RestorePDX
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97008
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs