Anterior Cruciate Ligament Reconstruction
Conditions
Brief summary
This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.
Interventions
BIOLOGICALAutologous Mesenchymal Stromal Cells
Autologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic visit approximately 21 days after completion of the surgery. After being removed from the patient, the cells will be cultured, modified, and harvested to become the final investigational product. Each subject will receive 1.5 ml of the investigative drug. This will contain 5x10\^7 (50 million) autologous MSCs.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft with the Principal Investigator (PI). * Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.
Exclusion criteria
* Under 18 years of age * Prior surgery on affected knee * Diabetes * Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary * Unable to attend physical therapy at Houston Methodist * Vulnerable populations * Immunocompromised patients such as those being treated for cancer, kidney failure, etc. * Heart disease (including systolic blood pressure \>180 mm Hg or heart failure) * Active infections * Non-English-speaking patients * Any known metal implants or allergy to contrast agents * Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study * Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections * Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed * Any other medical condition that in the opinion of the primary investigator would constitute a relative contraindication to study participation (e.g., Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, SLE, scleroderma, polymyositis, Ehlers-Danlos syndrome, osteoporosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop | Participants will be asked via a follow-up phone call following injection whether or not they have experienced any adverse events following the injection. They will be assessed at all remaining standard of care follow up visits and staff will inquire about adverse events. |
| Knee Function | Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop | Knee function will be assessed through patient reported responses on the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey via REDCap. The Questionnaire has five subscales which are separately scored (pain, function in daily living, function in sport and recreation, other symptoms and knee-related quality of life). Final score will be determined on a scale of 0-100 where 100 indicates no symptoms and 0 indicates extreme symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain | Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop | Pain levels will be assessed using patient reported outcomes via REDCap. The Visual Analogue Scale will ask participants to mark on a line, using a ruler, how much pain they are in. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
| Return to Sport Time | 3 months postop | Return to sport time will be evaluated via the subject's standard of care (SOC) physical therapy notes in their chart. |
| Knee Swelling | Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop | The trans-patellar circumference of both knees will be measured at the standard of care (SOC) appointments the subject will attend throughout the study to monitor swelling. Knees will be measured utilizing a flexible measuring tape and the affected knee will be compared to the unaffected knee to verify the difference in size, and therefore the severity of swelling. The greater the difference in size between knees, the more severe the swelling. |
Countries
United States
Contacts
CONTACTMadison Bowden
CONTACTHaley Goble
PRINCIPAL_INVESTIGATORPatrick McCulloch, MD
The Methodist Hospital Research Institute
Outcome results
None listed