Knee OsteoarthritisNCT03337243
Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
A study testing HAM and HUMCWJ Injections in people with Knee Osteoarthritis and Knee Pain Chronic, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to compare the pain, functioning and pain medication consumption of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord Wharton's Jelly (HUMCWJ) implanted into the… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Joint Disease
- What is being tested?
- HAM and HUMCWJ Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 26 Apr 2019
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA
Who cannot join
- Allergy to or use of penicillin, streptomycin, emphotericin B or dimethylsulfoxide. DMSO allergies and any immunocompromised conditions will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott Medical Health Center
Pittsburgh, Pennsylvania, 15220
About this study
The purpose of this study is to compare the pain, functioning and pain medication consumption of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who self-select to be in a non-intervention control group.
Read the detailed description
A total of 60 patients will be recruited from Scott Medical Health Center in Pittsburgh, PA. Inclusion criteria for the study are knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA. Recruitment will be done in two parts as participants will self-select to participate in one of two study groups. All participants who elect to have the procedure done at the initial consultation, meet inclusion criteria, and agree to be in the study will be placed in Group 1. Participants who do not wish to have the procedure, meet inclusion and exclusion criteria, and agree to be in the study will be placed in Group 2. Those participants who are unsure about the procedure and need more time to decide will be contacted 2 weeks later and then group will be determined by their decision. All participants will be required to sign a written informed consent prior to data collection. Following written consent, all participants will undergo data collection (T0). At T0, participants will complete a demographic and medication use questionnaire, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), knee survey, and be timed during a single trial of three functional tasks. Participants will also provide a pain rating while completing each of the functional tasks. Group 1 will then undergo HAMS injection to the OA affected knee immediately following the testing battery. Group 2 will delay the HAMS injection to the OA affected knee for at least 3 months or never receive the injection. All participants will complete T1 data collection approximately 4 weeks following completion of T0 data collection and T2 data collection approximately 3 months following completion of T0 data collection. The T1 and T2 data collections will use the same data collection procedures and questionnaires.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Joint Disease, Arthritis, Osteo Arthritis Knee, Musculoskeletal Disease
- Being tested
- HAM and HUMCWJ Injections
- Keywords
- Stem Cell Injection, Cytokine, Wharton's Jelly, Stem Cells
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Arthritis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAM and HUMCWJ InjectionsProcedure or surgery
SURGENEX SurForce® (1cc) allograft placental based tissue matrix, will be injected using a 22 gauge, 2-inch needle. The injection site (medial, lateral, patellar) will be determined based on the side with the most joint space from the findings of the most recent x-rays. The Physician will insert the needle fully into the joint space and begin to expel the fluid. He will achieve a continuous injection flow as he withdraws the needle back out of joint space. Immediately following the SURGENEX SurForce® injection, an injection of Predictive Biotech CORECYTE(TM) (1 cc) allograft umbilical cord-derived Warton's Jelly tissue matrix will be administered. This will be done using the exact same protocol as the SURGENEX SurForce® injection.
| Study group | Role | What they receive |
|---|---|---|
| HAM and HUMCWJ Injections (Group 1) | Experimental | Participants who self-select into the Group 1 (Immediate Treatment) will be scheduled to undergo the HAM and HUMCWJ injections to the OA affected knee at the same visit. Receives: Procedure: HAM and HUMCWJ Injections |
| Control (Group 2) | No intervention | Participants who self-select into Group 2 will choose to delay their HAM and HUMCWJ injection to the OA affected knee for at least 3 months or choose not to have the injections at all. Participants will be asked to keep track of pain management and therapy throughout the 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months
Measured: Baseline (T0), 4 weeks (T1), 3 months (T2)
Change in pain during sit-to-stand over 3 months
Participants will perform as many sit-to-stand movements as they can in 30 seconds and then will rate pain
Measured: Baseline (T0), 4 weeks (T1), 3 months (T2)
Change in pain during supine to upright over 3 months
Participants will perform a supine to upright movement as quickly as they can and then will rate pain
Measured: Baseline (T0), 4 weeks (T1), 3 months (T2)
Change in pain during ascent/decent stairs over 3 months
Participants will ascend and decent 10 stairs as quickly as they can and then will rate pain
Measured: Baseline (T0), 4 weeks (T1), 3 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start9 Nov 2017
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Hieronimus, Scott Medical Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337243
- Sponsor's protocol ID
- StemCell
- Status last verified
- May 2020
- First submitted
- 25 May 2017
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03337243
- Acronym / sponsor ID
- StemCell
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Joint Disease, Arthritis, Osteo Arthritis Knee, Musculoskeletal Disease
- Keywords
- Stem Cell Injection, Cytokine, Wharton's Jelly, Stem Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 8 Nov 2017 (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 purpose of this study is to compare the pain, functioning and pain medication consumption of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who self-select to be in a non-intervention control group.
Detailed description
A total of 60 patients will be recruited from Scott Medical Health Center in Pittsburgh, PA. Inclusion criteria for the study are knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA. Recruitment will be done in two parts as participants will self-select to participate in one of two study groups. All participants who elect to have the procedure done at the initial consultation, meet inclusion criteria, and agree to be in the study will be placed in Group 1. Participants who do not wish to have the procedure, meet inclusion and exclusion criteria, and agree to be in the study will be placed in Group 2. Those participants who are unsure about the procedure and need more time to decide will be contacted 2 weeks later and then group will be determined by their decision. All participants will be required to sign a written informed consent prior to data collection. Following written consent, all participants will undergo data collection (T0). At T0, participants will complete a demographic and medication use questionnaire, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), knee survey, and be timed during a single trial of three functional tasks. Participants will also provide a pain rating while completing each of the functional tasks. Group 1 will then undergo HAMS injection to the OA affected knee immediately following the testing battery. Group 2 will delay the HAMS injection to the OA affected knee for at least 3 months or never receive the injection. All participants will complete T1 data collection approximately 4 weeks following completion of T0 data collection and T2 data collection approximately 3 months following completion of T0 data collection. The T1 and T2 data collections will use the same data collection procedures and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAM and HUMCWJ Injections (Group 1) | Experimental | Procedure: HAM and HUMCWJ InjectionsParticipants who self-select into the Group 1 (Immediate Treatment) will be scheduled to undergo the HAM and HUMCWJ injections to the OA affected knee at the same visit. |
| Control (Group 2) | No intervention | –Participants who self-select into Group 2 will choose to delay their HAM and HUMCWJ injection to the OA affected knee for at least 3 months or choose not to have the injections at all. Participants will be asked to keep track of pain management and therapy throughout the 3 months. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA
Key exclusion criteria (1 listed)
- Allergy to or use of penicillin, streptomycin, emphotericin B or dimethylsulfoxide. DMSO allergies and any immunocompromised conditions will also be excluded
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 |
|---|---|---|
| HAM and HUMCWJ InjectionsSURGENEX SurForce® (1cc) allograft placental based tissue matrix, will be injected using a 22 gauge, 2-inch needle. The injection site (medial, lateral, patellar) will be determined based on the side with the most joint space from the findings of the most recent x-rays. The Physician will insert the needle fully into the joint space and begin to expel the fluid. He will achieve a continuous injection flow as he withdraws the needle back out of joint space. Immediately following the SURGENEX SurForce® injection, an injection of Predictive Biotech CORECYTE(TM) (1 cc) allograft umbilical cord-derived Warton's Jelly tissue matrix will be administered. This will be done using the exact same protocol as the SURGENEX SurForce® injection. | Procedure or surgery | HAM and HUMCWJ Injections (Group 1) |
Primary outcome
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months
Time frame: Baseline (T0), 4 weeks (T1), 3 months (T2)
Change in pain during sit-to-stand over 3 months
Time frame: Baseline (T0), 4 weeks (T1), 3 months (T2)
Participants will perform as many sit-to-stand movements as they can in 30 seconds and then will rate pain
Change in pain during supine to upright over 3 months
Time frame: Baseline (T0), 4 weeks (T1), 3 months (T2)
Participants will perform a supine to upright movement as quickly as they can and then will rate pain
Change in pain during ascent/decent stairs over 3 months
Time frame: Baseline (T0), 4 weeks (T1), 3 months (T2)
Participants will ascend and decent 10 stairs as quickly as they can and then will rate pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAM and HUMCWJ Injections in people with Knee Osteoarthritis and Knee Pain Chronic, run by Sport and Spine Rehab Clinical Research Foundation at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months (time frame: Baseline (T0), 4 weeks (T1), 3 months (T2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020.