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

Personalized Stem Cells

Status and phase: Unknown; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: PSC-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT04043819

PSC-CP-001

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

PSC-01

Experimental group

Description:

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

Treatment:

Drug: PSC-01