Knee OsteoarthritisPhase 1NCT04043819
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
A Phase 1 study testing PSC-01 in people with Knee Osteoarthritis, run by Personalized Stem Cells, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PSC-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Sep 2019to Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
RestorePDX
Beaverton, Oregon, 97008
San Diego Orthobiologics Medical Group
Carlsbad, California, 92011
New Jersey Regenerative Institute
Cedar Knolls, New Jersey, 07927
Cellular Orthopedics
Des Plaines, Illinois, 60016
Grossmont Orthopedic Medical Group
La Mesa, California, 91942
Synergy Orthopedic Specialists Medical Group
San Diego, California, 92121
The Orthohealing Center
Santa Monica, California, 90025
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- PSC-01
- Keywords
- cellular therapy, stromal vascular fraction, SVF, KOOS, autologous, mesenchymal stem cell, MSC, knee, osteoarthritis, adipose-derived mesenchymal stem cells, Ad-MSC, intraarticular
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSC-01Drug
PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.
| Study group | Role | What they receive |
|---|---|---|
| PSC-01 | Experimental | All study participants will receive intraarticular injection of the investigational biological product, PSC-01. Receives: Drug: PSC-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 months
Secondary outcomes (1)
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.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start7 Sep 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Personalized Stem Cells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043819
- Sponsor's protocol ID
- PSC-CP-001
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rogers CJ, Harman R, Sheinkop MB, Hanson P, Ambach MA, David T, Desai R, Sampson S, Aufierro D, Bowen J, Malanga G. Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis. Stem Cells Dev. 2024 Apr;33(7-8):168-176. doi: 10.1089/scd.2024.0008.
PubMed 38386505
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04043819
- Acronym / sponsor ID
- PSC-CP-001
- Conditions
- Knee Osteoarthritis
- Keywords
- cellular therapy, stromal vascular fraction, SVF, KOOS, autologous, mesenchymal stem cell, MSC, knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Personalized Stem Cells, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSC-01 | Experimental | Drug: PSC-01All study participants will receive intraarticular injection of the investigational biological product, PSC-01. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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:
- Prescribed immunosuppressive therapy at the time of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSC-01PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells. | Drug | PSC-01 |
Primary outcome
Incidence of Adverse Events
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.
1 secondary outcome
Changes in KOOS Measurement
Time frame: 3-4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 38386505Rogers CJ, Harman R, Sheinkop MB, Hanson P, Ambach MA, David T, Desai R, Sampson S, Aufierro D, Bowen J, Malanga G. Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis. Stem Cells Dev. 2024 Apr;33(7-8):168-176. doi: 10.1089/scd.2024.0008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PSC-01 in people with Knee Osteoarthritis, run by Personalized Stem Cells, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.