Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia

NCT01019681 | Terminated Phase 1

• 1 other identifier: PVD.Cord.Blood.2008
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether treatment with umbilical cord blood stem cells will improve blood flow to the most severely affected leg of a participant with medically refractory and non-surgical peripheral vascular disease of the lower extremity.

Conditions

Critical Limb Ischemia

Keywords

Cord blood injection in peripheral vascular disease

Outcome Measures

Primary Outcomes (3)

• Ankle brachial index (ABI), a 15% increase will be considered improvement

  Pre-transplant, 1, 6, 12 and 24 months after

• Healing of ischemic ulcers

  Pre-transplant, 1, 6, 12 and 24 months after

• Decreased pain level as reported by the patient

  Pre-transplant, 1, 6, 12 and 24 months after

Secondary Outcomes (4)

• SF-36 quality of life (QOL)

  Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant

• Walking Impairment Questionnaire

  Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant

• Increase in pain free ambulation time on treadmill by more than 25%

  Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant

• Increase in four meter walk or six minute walk by more than 25%

  Pre-transplant, 1, 6 , 12, and 24 months after HSC transplant

Study Arms (1)

UBC injection into one leg of PVD pt

EXPERIMENTAL

25 participants with severe peripheral vascular disease in leg(s) and they do not qualify for surgical treatment.

Biological: Cord blood stem cell injection

Interventions

Cord blood stem cell injection BIOLOGICAL

The cord blood stem cells will be simply injected intramuscularly in the leg. 30 minutes prior to stem cell injection the patients will receive Vancomycin 1 gram IVPB x1 as a prophylactic measure. Patients will also receive Ativan 0.5 to 1 mg PO x 1 and Dilaudid 0.5 to 1 mg IV x1 to alleviate the discomfort of the procedure. Cells will be injected by means of a 22 gauge sterile spinal needle after topical anesthesia of the injection site. The concentration will be at least 2 x 107 total nucleated cells per ml in phosphate buffered saline (PBS) with 5% human serum albumin (Baxter, Deerfield Illinois).

Also known as: HSCT

UBC injection into one leg of PVD pt

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV)
• Participant must match either a or b
• Ankle brachial index (ABI) ≤ 0.7
• Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure \< 30 mmHg.
• A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.
• Age \> 18 years old.

You may not qualify if:

• Patients must be on maximal tolerated medical therapy for PVD including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to \< 7.0 mg/dl, control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, control of hypertension as indicated C) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy)
• Popliteal vascular entrapment syndrome
• Lower extremity infection or infected ulcer
• Hypercoagulable state
• HIV positive
• HBsAg positive
• Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy
• Unstable angina
• Thrombocytopenia \< 50,000/ul
• Leukemia or myelodysplasia
• Allergy to E coli or its products
• Patients with metal in their bodies cannot undergo MRIs (MRA). Therefore, patients with, cochlear implants, or aneurysm clips are not eligible. Coronary artery stents are not a contraindication. Patients with pacemakers are still candidates provided they have normal creatinine (\< 1.1 mg/dl) and can receive contrast dye (no allergy) for angiogram instead of MRA. MRI/MRA does not need to be repeated if a prior MRA or Angiogram Demonstrates inoperable disease.
• Patients who are pregnant
• Current malignancy, except squamous cell or basal cell skin cancers thought to be easily controlled.
• AST, ALT, or bilirubin more than twice the upper limit of normal.

Sponsors & Collaborators

• Richard Burt, MD: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Burt, MD

  Northwestern University and Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (1)