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

October 26, 2024 updated by: Michael Murphy

Safety and Efficacy of Concentrated Autologous Concentrated Bone Marrow Aspirate (cBMA) in Preventing Wound Complications in Below Knee Amputation (BKA) (The MarrowCHAMP Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients scheduled for amputation will receive bone marrow cells concentrated via the MarrowStim device (cBMA) injected IM at 25 sites in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery. cBMA will be injected into the anterior tibialis muscle below the point of amputation in an area approximately 3cm^2 x 2cm^2 for analytical purposes. Patients will be scheduled for amputation at Days 7, 14, or 21 post injection. Safety will be evaluated by review of treatment related adverse events (AE) during the 52-week follow-up period. The investigator will compare rates of wound complications and amputation revisions to historical controls at the institution to assess trends in therapeutic efficacy.

Patients will undergo amputation and injection sites will be harvested at that time. Immunohistochemical staining (IHC) will determine capillary density and local host immune responses. Angiogenic and inflammatory cytokines will be quantified using a multiplex array system and quantitative polymerase chain reaction (PCR).

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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).
  5. 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:

  1. Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating.
  2. Significant hepatic dysfunction (ALT or AST greater than 2 times normal).
  3. CHF hospitalization within the last 1 month prior to enrollment.*
  4. Acute coronary syndrome (ACS) in the last 1 month prior to enrollment.*
  5. HIV positive, or active, untreated HCV.
  6. History of cancer within the last 5 years, except basal cell skin carcinoma
  7. Any bleeding diathesis defined as an INR ≥ 2.0 (off anticoagulation therapy) or history of platelet count less than 70,000 or hemophilia.
  8. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).
  9. Concurrent enrollment in another clinical investigative trial.
  10. Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata).

  11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Day 7
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
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Other Names:
  • concentrated bone marrow
  • cBMA
Experimental: Day 14
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
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Other Names:
  • concentrated bone marrow
  • cBMA
Experimental: Day 21
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
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Other Names:
  • concentrated bone marrow
  • cBMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events Occurring During the Enrollment Period as Assessed by the Investigator Using the CTCAE 4.0 Scale.
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
Documentation will be collected on wound complications at the below knee amputation surgical site resulting in necessity of revision/conversion to above knee amputation.
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.
Time Frame: 12 months
Continuous confidence intervals at the 95% level will be constructed to explore differences among the time-tiered administration of MSC for the quantity of capillary density in muscle fibers.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Murphy

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Michael P Murphy, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2017

Primary Completion (Actual)

July 27, 2018

Study Completion (Actual)

July 27, 2018

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimated)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2024

Last Update Submitted That Met QC Criteria

October 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1511774456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared with investigators at the Indiana University School of Medicine as well as at other collaborating institutions.

IPD Sharing Time Frame

Data will become available as it is generated and will be available for future, yet-to-be-written protocols.

IPD Sharing Access Criteria

Access to de-identified data will be granted for future PI approved indications.

IPD Sharing Supporting Information Type

  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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