Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02863926 | Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA) | PHASE1 | COMPLETED | 6 | — | — | Jan 6, 2017 | Jul 27, 2018 | Dec 12, 2024 | 1 | United States |
Safety will be evaluated by review of treatment related AEs during the 12-month follow-up period. The study will be terminated in the event of a Grade 4-5 unexpected event based on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-related AEs will be categorized overlapping systems and severities. Three categories of systems are cardiovascular, respiratory, or infectious. Two categories of severity will be serious adverse (SAE) and major adverse cardiac events (MACE). Binomial confidence Intervals at the 95% confidence level and p-values for these 3 groups will be calculated. Since previous trials have not reported AEs with cBMA treatment, confidence intervals will be generated by the method of the Wilson Score Interval.
| Arm | Type | Description |
|---|---|---|
| Day 7 | EXPERIMENTAL | BKA performed at 7 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg |
| Day 14 | EXPERIMENTAL | BKA performed at 14 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg |
| Day 21 | EXPERIMENTAL | BKA performed at 21 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg |
| Name | Type | Description |
|---|---|---|
| Injection of cBMA aspirate into the index leg | BIOLOGICAL | Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery |
Inclusion Criteria: 1. Be ≥ 40 and ≤90 years of age. 2. Patients requiring below knee amputation, as determined by an independent vascular specialist. 3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM for 4 injections 4 cm. apart) 4. BKA can safely be p...