Phase 1
N=6
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Peripheral Artery Disease · Vascular Disease · Critical Limb Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT02863926 ↗Enrolled (actual)
6
Serious AEs
83.3%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events Occurring During the Enrollment Period as Assessed by the Investigator Using the CTCAE 4.0 Scale. — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Injection of cBMA aspirate into the index leg (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Michael Murphy
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events Occurring During the Enrollment Period as Assessed by the Investigator Using the CTCAE 4.0 Scale. |
2; 0 | — |
| SECONDARY Number of Participants With Conversion From Below Knee Amputation to Above Knee Amputation as Evidenced by Wound Complications at the Below Knee Amputation Stump Site. |
0; 0 | — |
| SECONDARY The Role of Autologous Bone Marrow Cells Injected in Human Skeletal Muscle in Inducing Capillary Vessel Formation at the Time of Below Knee Amputation. |
1.089; 1.431; 1.373; 1.673; 1.064; 1.526 | — |
Summary
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
Eligibility Criteria
Inclusion Criteria
- Be ≥ 40 and ≤90 years of age.
- Patients requiring below knee amputation, as determined by an independent vascular specialist.
- If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM for 4 injections 4 cm. apart)
- BKA can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon. This information will be documented in subjects' case report forms (CRFs).
- Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening.
Exclusion Criteria
- Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating.
- Significant hepatic dysfunction (ALT or AST greater than 2 times normal).
- CHF hospitalization within the last 1 month prior to enrollment.*
- Acute coronary syndrome (ACS) in the last 1 month prior to enrollment.*
- HIV positive, or active, untreated HCV.
- History of cancer within the last 5 years, except basal cell skin carcinoma
- Any bleeding diathesis defined as an INR ≥ 2.0 (off anticoagulation therapy) or history of platelet count less than 70,000 or hemophilia.
- Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).
- Concurrent enrollment in another clinical investigative trial.
- Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata).
- Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial.
- As defined by the standard definitions of CHF and ACS by the American Heart Association.
Data sourced from ClinicalTrials.gov (NCT02863926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.