Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)

NCT02863926 | Completed Phase 1 Results DMC

• 1 other identifier: 1511774456
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Disease; Vascular Disease; Critical Limb Ischemia

Keywords

BKA; amputation; MarrowStim; below knee amputation; wound complication; vascular disease; critical limb ischemia; peripheral artery disease; AKA; stem cells; bone marrow

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events Occurring During the Enrollment Period as Assessed by the Investigator Using the CTCAE 4.0 Scale.

  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.

  12 months

Secondary Outcomes (2)

• 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.

  12 months

• The Role of Autologous Bone Marrow Cells Injected in Human Skeletal Muscle in Inducing Capillary Vessel Formation at the Time of Below Knee Amputation.

  12 months

Study Arms (3)

Day 7

EXPERIMENTAL

BKA performed at 7 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg

Biological: 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

Biological: 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

Biological: Injection of cBMA aspirate into the index leg

Interventions

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

Also known as: concentrated bone marrow, cBMA

Day 14; Day 21; Day 7

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Murphy: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Limitations and Caveats

COVID-19 research activities Hold leading to slower enrollment and Cost-prohibitive to resume enrollment at VA for additional participants leading to early closure of study and low enrollment.

Results Point of Contact

• Title: Kristen Wanczyk / Certified Clinical Research Nurse Coordinator
• Organization: Indiana University School of Medicine

keevans@iu.edu

317-7988-9548

Study Officials

• Michael P Murphy, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: Autologous bone marrow derived mesenchymal stromal cells will be delivered intramuscularly in the lower extremity of participants undergoing lower extremity major amputation to assess incidence of wound healing and infection prevention.

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: August 11, 2016
• Study Start: January 6, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will become available as it is generated and will be available for future, yet-to-be-written protocols.
• Access Criteria: Access to de-identified data will be granted for future PI approved indications.

Locations

US (1)