Osteoarthritis, KneeEarly Phase 1NCT06608134
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Knee Osteoarthritis
A Early Phase 1 study testing Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection in people with Osteoarthritis, Knee, run by R3 Medical Research at 5 sites in United States.
Trial summary
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2024to 1 Oct 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over age 30
- Diagnosed with Grade II or III OA on the KL scale (in one knee).
- Body Mass Index (BMI) <50Kg/m2
- Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
- Female patients must be abstinent, surgically sterilized or postmenopausal
- Premenopausal females must have a negative pregnancy test, on contraceptive measures and do not anticipate pregnancy during the duration of the study.
- Be willing and capable of giving written informed consent to participate in English.
- Be willing and capable of complying with study-related requirements, procedures and visits in English.
Who cannot join
- Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
- Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
- Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
- Have had surgery on the index knee with the past 6 months.
- Had a traumatic injury to the index knee with the past 3 months.
- Planned elective surgery during the course of the study.
Show all 16Show fewer
- A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
- Be on immunosuppressive medications.
- Have a diagnosis of carcinoma with the past 2 years.
- Have a knee infection or have used antibiotics for knee infection within the past 3 months.
- Have participated in any other clinical trial or treatment (not just for the knee, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
- Female patients who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
- Contraindications to radiographic or MRI imaging.
- Serious neurological, psychological or psychiatric disorders.
- Injury or disability claims under current litigation or pending or approved workers compensation claims.
- Have a known drug allergy to amphotericin-B, ciprofloxacin, gentamycin, penicillin, or streptomycin.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
R3 Anti Aging Beverly Hills
Beverly Hills, California, 90210
Neville Campbell, MD, 424-382-1074, info@r3medicalresearch.com
- Recruiting
Dr. Duc (Steve) Le, MD
Cleveland, Texas, 77327
Duc Le, MD, 281-593-1500, info@r3medicalresearch.com
Duc L, MD
- Recruiting
Optimal Medical Group
Fresno, California, 93722
Dr. Lucia Mireles-Chavez, MD, 559-425-1118, info@r3medicalresearch.com
- Recruiting
Scheer Medical Wellness
New York, New York, 10036
Dr. Alexandre Scheer, MD, 212-391-8080, info@r3medicalresearch.com
- Recruiting
R3 Anti Aging Scottsdale
Scottsdale, Arizona, 85262
Dr. Sabrina Solt, NMD, 480-306-6256, info@r3medicalresearch.com
About this study
Official title: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
Read the detailed description
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
- Keywords
- umbilical cord, Whartons Jelly, Allograft, knee pain, knee arthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee InjectionBiological
Direct injection of biologic into the knee joint.
| Study group | Role | What they receive |
|---|---|---|
| 2cc WJ Allograft (Low Dose) | Active comparator | The 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group. Receives: Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection |
| 3cc WJ Allograft (Medium Dose) | Active comparator | The 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group. Receives: Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection |
| 4cc WJ Allograft (High Dose) | Active comparator | The 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group. Receives: Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reactive Protein
C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body. A simple blood test can check your C-reactive protein level.
C-reactive protein is measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L are considered high. Range values vary depending on the lab doing the test.
A high test result is a sign of inflammation. It may be due to serious infection, injury or chronic disease. Your health care provider may recommend other tests to determine the cause.
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Erythrocyte Sedimentation Rate
Sed rate, or erythrocyte sedimentation rate (ESR), is a blood test that can show inflammatory activity in the body.
Because a sed rate test can't pinpoint the problem that's causing inflammation in your body, it's often accompanied by other blood tests, such as the C-reactive protein (CRP) test.
ESR is measured in millimeters per hour (mm/hr). The normal values are:
0 to 15 mm/hr in men 0 to 20 mm/hr in women
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Alanine Transaminase
ALT is an enzyme that converts proteins into energy for the liver cells. Aspartate transaminase (AST). AST is an enzyme that helps the body break down amino acids. Alkaline phosphatase (ALP). ALP is an enzyme important for breaking down proteins. Albumin and total protein. Albumin is a protein made in the liver. Bilirubin. Bilirubin is a substance produced during the breakdown of red blood cells. Gamma-glutamyltransferase (GGT). Higher-than-usual may mean liver damage. L-lactate dehydrogenase (LD). LD is an enzyme found in the liver. Prothrombin time (PT). PT is the time it takes your blood to clot. Standard range:
Alanine transaminase (ALT). ALT is an enzyme that converts proteins into energy for the liver cells. Standard range:
ALT. 7 to 55 units per liter U/L.
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Aspartate Transaminase
AST is an enzyme that helps the body break down amino acids. . Standard range: AST 8 to 48 units per liter
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Alkaline Phosphatase
ALP is an enzyme important for breaking down proteins. Standard range: 40 to 129 units per liter
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Albumin
Albumin is a protein made in the liver. Normal range is 34 to 54 grams/liter.
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Creatinine
Creatinine is a waste product that comes from the digestion of protein in your food and the normal breakdown of muscle tissue. It is removed from the blood through your kidneys. Everyone has some creatinine in their blood, but too much can be a sign of a possible kidney problem. Normal range is 0.6-1.3 milligrams/deciliter
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Blood Urea Nitrogen
blood urea nitrogen (BUN) test reveals important information about how well your kidneys are working. A BUN test measures the amount of urea nitrogen that's in your blood. Normal BUN is 6-20 milligrams/deciliter.
Measured: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Secondary outcomes (3)
36-Item Short Form Survey (SF-36)
The SF-36 is used as an assessment tool to measure a quality of life. The SF-36 is comprehensive health survey with a total of 36 questions divided into eight categories, including physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). The score averages for each category range from 0 to 100, with a higher score defining a more favorable outcome.
Measured: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Numerical Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Knee Injury and Osteoarthritis Outcome Score
This survey asks for your view about your knee. This information will help us keep track of how you feel about your knee and how well you are able to perform your usual activities.
Measured: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, prospective, open label, dose escalation, non-controlled
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R3 Medical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608134
- Sponsor's protocol ID
- R3-WJI-001
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: R3 Medical Research will share study materials in a blinded fashion with no participant identifying information to participating researchers as needed.
Publications
Cisternas MG, Murphy L, Sacks JJ, Solomon DH, Pasta DJ, Helmick CG. Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey. Arthritis Care Res (Hoboken). 2016 May;68(5):574-80. doi: 10.1002/acr.22721.
PubMed 26315529Van Manen MD, Nace J, Mont MA. Management of primary knee osteoarthritis and indications for total knee arthroplasty for general practitioners. J Am Osteopath Assoc. 2012 Nov;112(11):709-15.
PubMed 23139341Losina E, Thornhill TS, Rome BN, Wright J, Katz JN. The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic. J Bone Joint Surg Am. 2012 Feb 1;94(3):201-7. doi: 10.2106/JBJS.J.01958.
PubMed 22298051Gupta A, Potty ASR, Ganta D, Mistovich RJ, Penna S, Cady C, Potty AG. Streamlining the KOOS Activities of Daily Living Subscale Using Machine Learning. Orthop J Sports Med. 2020 Mar 24;8(3):2325967120910447. doi: 10.1177/2325967120910447. eCollection 2020 Mar.
PubMed 32270015Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC; ASA Study Group. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. 2019 Nov;32(11):1143-1154. doi: 10.1055/s-0039-1696672. Epub 2019 Sep 18.
PubMed 31533151Hoorntje A, Witjes S, Koenraadt KLM, Aarts R, Weert T, van Geenen RCI. More Severe Preoperative Kellgren-Lawrence Grades of Knee Osteoarthritis were Partially Associated with Better Postoperative Patient-Reported Outcomes in TKA Patients. J Knee Surg. 2019 Mar;32(3):211-217. doi: 10.1055/s-0038-1635114. Epub 2018 Feb 28.
PubMed 29490401Kahn TL, Soheili A, Schwarzkopf R. Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative. Geriatr Orthop Surg Rehabil. 2013 Dec;4(4):117-26. doi: 10.1177/2151458514520634.
PubMed 24600532Eyichukwu GO. Non-Steroidal anti inflammatory drugs usage in orthopaedics and trauma practice. A guide and review. Niger J Med. 2010 Oct-Dec;19(4):374-81. doi: 10.4314/njm.v19i4.61959.
PubMed 21526623Yasir M, Goyal A, Sonthalia S. Corticosteroid Adverse Effects. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531462/
PubMed 30285357Gupta A, Woods MD, Illingworth KD, Niemeier R, Schafer I, Cady C, Filip P, El-Amin SF 3rd. Single walled carbon nanotube composites for bone tissue engineering. J Orthop Res. 2013 Sep;31(9):1374-81. doi: 10.1002/jor.22379. Epub 2013 Apr 29.
PubMed 23629922Lamplot JD, Rodeo SA, Brophy RH. A Practical Guide for the Current Use of Biologic Therapies in Sports Medicine. Am J Sports Med. 2020 Feb;48(2):488-503. doi: 10.1177/0363546519836090. Epub 2019 Apr 30.
PubMed 31038990Rodriguez HC, Gupta M, Cavazos-Escobar E, El-Amin SF 3rd, Gupta A. Umbilical cord: an allogenic tissue for potential treatment of COVID-19. Hum Cell. 2021 Jan;34(1):1-13. doi: 10.1007/s13577-020-00444-5. Epub 2020 Oct 9.
PubMed 33033884Gupta A, Cady C, Fauser AM, Rodriguez HC, Mistovich RJ, Potty AGR, Maffulli N. Cell-free Stem Cell-Derived Extract Formulation for Regenerative Medicine Applications. Int J Mol Sci. 2020 Dec 9;21(24):9364. doi: 10.3390/ijms21249364.
PubMed 33316880Main BJ, Maffulli N, Valk JA, Rodriguez HC, Gupta M, El-Amin SF 3rd, Gupta A. Umbilical Cord-Derived Wharton's Jelly for Regenerative Medicine Applications: A Systematic Review. Pharmaceuticals (Basel). 2021 Oct 27;14(11):1090. doi: 10.3390/ph14111090.
PubMed 34832872Gupta A, El-Amin SF 3rd, Levy HJ, Sze-Tu R, Ibim SE, Maffulli N. Umbilical cord-derived Wharton's jelly for regenerative medicine applications. J Orthop Surg Res. 2020 Feb 13;15(1):49. doi: 10.1186/s13018-020-1553-7.
PubMed 32054483
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for
- ClinicalTrials.gov ID
- NCT06608134
- Acronym / sponsor ID
- R3-WJI-001
- Conditions
- Osteoarthritis, Knee
- Keywords
- umbilical cord, Whartons Jelly, Allograft, knee pain, knee arthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- R3 Medical ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 23 Sep 2024 (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.
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled evaluating safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee osteoarthritis. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
Detailed description
This is a Pilot Study which is randomized, prospective, open label, dose escalation, non-controlled study in which the safety and feasibility of intra-articular Wharton's Jelly (WJ) allograft will be evaluated in patients suffering with knee OA. The participants will be randomized to one of three dosing treatment arms that will consist of one intra-articular knee injection containing either low dose, medium dose or high dose WJ allograft tissue.
As this is a Pilot Study primarily designed to evaluate safety, no control will be used. The dosing groups will consist of either 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), or 4cc WJ Allograft (High Dose) with 120 total patients randomized into the three arms equally. In addition to baseline outcome instruments along with imaging and laboratory studies, patients will be followed for one year for evaluation of safety, pain relief and functional improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- randomized, prospective, open label, dose escalation, non-controlled
| Arm | Type | Receives |
|---|---|---|
| 2cc WJ Allograft (Low Dose) | Active comparator | Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee InjectionThe 2cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Low Dose Group. |
| 3cc WJ Allograft (Medium Dose) | Active comparator | Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee InjectionThe 3cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the Medium Dose Group. |
| 4cc WJ Allograft (High Dose) | Active comparator | Biological: Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee InjectionThe 4cc Whartons Jelly Allograft group receives an intra-articular knee injection and is considered the High Dose Group. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be over age 30
- Diagnosed with Grade II or III OA on the KL scale (in one knee).
- Body Mass Index (BMI) <50Kg/m2
- Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS)
- Female patients must be abstinent, surgically sterilized or postmenopausal
Key exclusion criteria (16 listed)
- Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
- Use anticoagulants have a substance abuse history and fail to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to the site principal investigator and study team.
- Have had an intra-articular injection of any drug including viscosupplementation in the index knee in the past 6 months.
- Have had surgery on the index knee with the past 6 months.
- Had a traumatic injury to the index knee with the past 3 months.
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 |
|---|---|---|
| Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee InjectionDirect injection of biologic into the knee joint. | Biological | 2cc WJ Allograft (Low Dose), 3cc WJ Allograft (Medium Dose), 4cc WJ Allograft (High Dose) |
Primary outcome
C Reactive Protein
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
C-reactive protein (CRP) is a protein made by the liver. The level of CRP increases when there's inflammation in the body. A simple blood test can check your C-reactive protein level. C-reactive protein is measured in milligrams per liter (mg/L). Results equal to or greater than 8 mg/L or 10 mg/L are considered high. Range values vary depending on the lab doing the test. A high test result is a sign of inflammation. It may be due to serious infection, injury or chronic disease. Your health care provider may recommend other tests to determine the cause.
Erythrocyte Sedimentation Rate
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Sed rate, or erythrocyte sedimentation rate (ESR), is a blood test that can show inflammatory activity in the body. Because a sed rate test can't pinpoint the problem that's causing inflammation in your body, it's often accompanied by other blood tests, such as the C-reactive protein (CRP) test. ESR is measured in millimeters per hour (mm/hr). The normal values are: 0 to 15 mm/hr in men 0 to 20 mm/hr in women
Alanine Transaminase
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
ALT is an enzyme that converts proteins into energy for the liver cells. Aspartate transaminase (AST). AST is an enzyme that helps the body break down amino acids. Alkaline phosphatase (ALP). ALP is an enzyme important for breaking down proteins. Albumin and total protein. Albumin is a protein made in the liver. Bilirubin. Bilirubin is a substance produced during the breakdown of red blood cells. Gamma-glutamyltransferase (GGT). Higher-than-usual may mean liver damage. L-lactate dehydrogenase (LD). LD is an enzyme found in the liver. Prothrombin time (PT). PT is the time it takes your blood to clot. Standard range: Alanine transaminase (ALT). ALT is an enzyme that converts proteins into energy for the liver cells. Standard range: ALT. 7 to 55 units per liter U/L.
Aspartate Transaminase
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
AST is an enzyme that helps the body break down amino acids. . Standard range: AST 8 to 48 units per liter
Alkaline Phosphatase
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
ALP is an enzyme important for breaking down proteins. Standard range: 40 to 129 units per liter
Albumin
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Albumin is a protein made in the liver. Normal range is 34 to 54 grams/liter.
Creatinine
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
Creatinine is a waste product that comes from the digestion of protein in your food and the normal breakdown of muscle tissue. It is removed from the blood through your kidneys. Everyone has some creatinine in their blood, but too much can be a sign of a possible kidney problem. Normal range is 0.6-1.3 milligrams/deciliter
Blood Urea Nitrogen
Time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year
blood urea nitrogen (BUN) test reveals important information about how well your kidneys are working. A BUN test measures the amount of urea nitrogen that's in your blood. Normal BUN is 6-20 milligrams/deciliter.
3 secondary outcomes
36-Item Short Form Survey (SF-36)
Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Numerical Pain Rating Scale (NPRS)
Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline, 24 hours after intervention, 1 week, 6 weeks, 3 months, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Results publication: PubMed 26315529Cisternas MG, Murphy L, Sacks JJ, Solomon DH, Pasta DJ, Helmick CG. Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey. Arthritis Care Res (Hoboken). 2016 May;68(5):574-80. doi: 10.1002/acr.22721.
- Results publication: PubMed 23139341Van Manen MD, Nace J, Mont MA. Management of primary knee osteoarthritis and indications for total knee arthroplasty for general practitioners. J Am Osteopath Assoc. 2012 Nov;112(11):709-15.
- Results publication: PubMed 22298051Losina E, Thornhill TS, Rome BN, Wright J, Katz JN. The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic. J Bone Joint Surg Am. 2012 Feb 1;94(3):201-7. doi: 10.2106/JBJS.J.01958.
- Results publication: PubMed 32270015Gupta A, Potty ASR, Ganta D, Mistovich RJ, Penna S, Cady C, Potty AG. Streamlining the KOOS Activities of Daily Living Subscale Using Machine Learning. Orthop J Sports Med. 2020 Mar 24;8(3):2325967120910447. doi: 10.1177/2325967120910447. eCollection 2020 Mar.
- Results publication: PubMed 31533151Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC; ASA Study Group. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. 2019 Nov;32(11):1143-1154. doi: 10.1055/s-0039-1696672. Epub 2019 Sep 18.
- Results publication: PubMed 29490401Hoorntje A, Witjes S, Koenraadt KLM, Aarts R, Weert T, van Geenen RCI. More Severe Preoperative Kellgren-Lawrence Grades of Knee Osteoarthritis were Partially Associated with Better Postoperative Patient-Reported Outcomes in TKA Patients. J Knee Surg. 2019 Mar;32(3):211-217. doi: 10.1055/s-0038-1635114. Epub 2018 Feb 28.
- Results publication: PubMed 24600532Kahn TL, Soheili A, Schwarzkopf R. Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative. Geriatr Orthop Surg Rehabil. 2013 Dec;4(4):117-26. doi: 10.1177/2151458514520634.
- Results publication: PubMed 21526623Eyichukwu GO. Non-Steroidal anti inflammatory drugs usage in orthopaedics and trauma practice. A guide and review. Niger J Med. 2010 Oct-Dec;19(4):374-81. doi: 10.4314/njm.v19i4.61959.
- Results publication: PubMed 30285357Yasir M, Goyal A, Sonthalia S. Corticosteroid Adverse Effects. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531462/
- Results publication: PubMed 23629922Gupta A, Woods MD, Illingworth KD, Niemeier R, Schafer I, Cady C, Filip P, El-Amin SF 3rd. Single walled carbon nanotube composites for bone tissue engineering. J Orthop Res. 2013 Sep;31(9):1374-81. doi: 10.1002/jor.22379. Epub 2013 Apr 29.
- Results publication: PubMed 31038990Lamplot JD, Rodeo SA, Brophy RH. A Practical Guide for the Current Use of Biologic Therapies in Sports Medicine. Am J Sports Med. 2020 Feb;48(2):488-503. doi: 10.1177/0363546519836090. Epub 2019 Apr 30.
- Results publication: PubMed 33033884Rodriguez HC, Gupta M, Cavazos-Escobar E, El-Amin SF 3rd, Gupta A. Umbilical cord: an allogenic tissue for potential treatment of COVID-19. Hum Cell. 2021 Jan;34(1):1-13. doi: 10.1007/s13577-020-00444-5. Epub 2020 Oct 9.
- Individual participant dataSharing planned: Yes. R3 Medical Research will share study materials in a blinded fashion with no participant identifying information to participating researchers as needed.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Umbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection in people with Osteoarthritis, Knee, run by R3 Medical Research at 5 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 8 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: looking for participants now, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C Reactive Protein (time frame: Baseline, 1 week after the procedure, 6 weeks, 3 months, 6 months and one year). The study lists 8 primary outcomes in all. 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 NCT06608134, which also lists 16 linked publications.
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 23 Sep 2024.