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

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Personalized Stem Cells, Inc.

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.