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Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043819
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Personalized Stem Cells, Inc.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: PSC-01 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: PSC-01
All study participants will receive intraarticular injection of the investigational biological product, PSC-01.
Drug: 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.




Primary Outcome Measures :
  1. Safety of PSC-01 [ Time Frame: 3-4 months ]
    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 :
  1. Efficacy of PSC-01 [ Time Frame: 3-4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04043819


Contacts
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Contact: Michael Dale 833-772-3557 mdale@pscells.com
Contact: Customer Service info@pscells.com

Sponsors and Collaborators
Personalized Stem Cells, Inc.

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Responsible Party: Personalized Stem Cells, Inc.
ClinicalTrials.gov Identifier: NCT04043819     History of Changes
Other Study ID Numbers: PSC-CP-001
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Personalized Stem Cells, Inc.:
cellular therapy
mesenchymal stem cell
adipose-derived mesenchymal stem cells
stromal vascular fraction
SVF
KOOS
autologous
MSC
knee
osteoarthritis
Ad-MSC
intraarticular
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases