Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia A double blind placebo controlled study in diabetic and non-diabetic patients

Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia A double blind placebo controlled study in diabetic and non-diabetic patients - Autologous bone marrow for peripheral artery disease.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37216

Enrollment

100

Registered

2007-02-08

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

claudication

Interventions

Bone marrow will be harvested from the iliac crest (700-800 ml) and the BM-MNC concentrated to a final volume of 40 mL (average total cell count 1.5-6.0 109 cells). Patients in the placebo group will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with persistent (>3 months, despite optimal treatment) disabling claudication or with critical leg ischemia (Fontaine's stages IIb-IV or Rutherford's categories 3-6) without adequate options for improvements by PTA or reconstructive surgery will be included in the study.

Exclusion criteria

Exclusion criteria: candidates for angioplasty or bypass procedures -inability to undergo bone marrow harvesting -any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM-MNC treatment

Design outcomes

Primary

Measure	Time frame
Primary endpoints are pain free walking distance (Fontaine IIb/III), and limb salvage/wound healing (Fontaine IV) at t=6 months.	—

Secondary

Measure	Time frame
Secondary endpoints include quality of life (RAND-36), walking impairment score, pain scores, ABI at t=3, 6 and 12 months, Limb salvage/wound healing at t=12 months as well as pain free walking distance at t=3 and 12 months. Upon reaching the primary endpoint (t=6 months), the study will commence as an open study. Patients in the placebo arm will be offered their frozen bone marrow. Results of this intervention will be analyzed separately.	—

Measure

Time frame

Secondary endpoints include quality of life (RAND-36), walking impairment score, pain scores, ABI at t=3, 6 and 12 months, Limb salvage/wound healing at t=12 months as well as pain free walking distance at t=3 and 12 months. Upon reaching the primary endpoint (t=6 months), the study will commence as an open study. Patients in the placebo arm will be offered their frozen bone marrow. Results of this intervention will be analyzed separately.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)